fnctId=bbs,fnctNo=2860 말머리 분류 전체 제1저자 공저자 교신저자 103 건 게시물 검색 제목 작성자 Journal 공통(상단고정) 공지 게시글 게시글 리스트 [제1저자] Influenza and anosmia: Important prediction factors for severity and death of COVID-19 작성자 김민걸 Year 2021 Journal J Infect 추천 0 비추천 0 조회수 165 첨부파일 1 Objectives To investigate the factors related to the severity and mo rtality of COVID-19 using big data-machine learning techniques. Methods This study included 8070 patients in South Korea diagnosed with COVID-19 between January and July 2020, and whose data were available from the National-Health-Insurance-Service. Results Machine-learning algorithms were performed to evaluate the effects of comorbidities on severity and mortality of COVID-19. The most common comorbidities of COVID-19 were pulmonary inflammation followed by hypertension. The model that best predicted severity was a neural network (AUC: 85.06%). The most important variable for predicting severity in the neural network model was a history of influenza (relative importance: 0.083). The model that best predicted mortality was the logistic regression elastic net (EN) model (AUC: 93.86%). The most important variables for mortality in the EN model were age (coefficient: 2.136) and anosmia (coefficient: -1.438). Conclusions In COVID-19 patients, influenza was found to be a major adverse factor in addition to old age and male. In addition, anosmia was found to be a major factor associated with lower severity and mortality. Therefore, in the current situation where there is no adequate COVID-19 treatment at present, examining the patient's history of influenza vaccination and anosmia in addition to age and sex will be an important indicator for predicting the severity and mortality of COVID-19 patients.Keywords: COVID 19; Comorbidities; Machine learning; Modeling; Mortality; SARS-CoV-2; Severity. [교신저자] Pharmacokinetics of a New, Once-Daily, Sustained-Release Pregabalin Tablet in Healthy Male Volunteers 작성자 김민걸 Year 2021 Journal Clin Ther 추천 1 비추천 0 조회수 105 첨부파일 0 Purpose: A new sustained-release (SR) pregabalin formulation (YHD1119) designed for once-daily dosing has recently been developed to improve patient adherence. This study aimed to compare the pharmacokinetics of pregabalin SR and immediate-release (IR) formulations after multiple oral doses and to assess the effect of food on the pharmacokinetic profile of the pregabalin SR formulation after a single dose in healthy individuals.Methods: Two clinical trials were conducted: a randomized, open-label, multiple-dose, 2-treatment, 2-period crossover study to evaluate the steady-state pharmacokinetic properties of SR treatment (pregabalin SR 300 mg once daily for 3 days) and IR treatment (pregabalin IR 150 mg twice daily for 3 days) under fed conditions and a randomized, open-label, single-dose, 2-treatment, 2-period, crossover study to evaluate the effect of food intake on the pharmacokinetic properties of the pregabalin SR formulation. Plasma concentrations of pregabalin were measured using LC-MS/MS. The AUC and Cmax for pregabalin were calculated using noncompartmental method and compared between treatments in each study.Findings: Thirty-one individuals in the bioequivalence study and 23 in the food effect study completed the pharmacokinetic sampling. The geometric mean ratios of Cmax,ss and AUC0-τ between the SR and IR formulations were 1.1642 (90% CI, 1.1043-1.2272) and 0.9704 (90% CI, 0.9372-1.0047), respectively. The geometric mean ratios of Cmax and AUC0-last between the SR formulation in the fed state and in the fasted state were 1.6514 (90% CI, 1.3820-1.9732) and 1.7899 (90%CI, 1.4499-2.2097), respectively.Implications: The bioavailability of the pregabalin SR 300 mg formulation is increased if taken with a high-fat meal. Once-daily pregabalin SR 300 mg is bioequivalent to twice-daily pregabalin IR 150 mg under fed conditions at steady state. The pregabalin SR formulation is expected to improve patient adherence. ClinicalTrials.gov identifiers: NCT02783183 (bioequivalence study) and NCT03191136 (food effect study).Keywords: food effect; pharmacokinetics; pregabalin; sustained release. [교신저자] Urinary Metabolomic Profiling after Administration of Corydalis Tuber and Pharbitis Seed Extract in Healthy Korean Volunteers 작성자 김민걸 Year 2021 Journal Pharmaceutics. 추천 0 비추천 0 조회수 79 첨부파일 1 Pharmacometabolomics is a useful tool to identify biomarkers that can assess and predict response after drug administration. The primary purpose of pharmacometabolomics is to better understand the mechanisms and pathways of a drug by searching endogenous metabolites that have significantly changed after drug administration. DA-9701, a prokinetic agent, consists of Pharbitis seed and Corydalis tube extract and it is known to improve the gastrointestinal motility. Although the overall mechanism of action of DA-9701 remains unclear, its active ingredients, corydaline and chlorogenic acid, act as a 5-HT3 and D2 receptor antagonist and 5-HT4 receptor agonist. To determine the significant metabolites after the administration of DA-9701, a qualitative analysis was carried out using ultra-high performance liquid chromatography coupled with orbitrap mass spectrometer followed by a multivariate analysis. Seven candidates were selected and a statistical analysis of fold change was performed over time. Our study concluded that all the seven selected metabolites were commonly involved in lipid metabolism and purine metabolism.Keywords: DA-9701; HRMS; metabolomics; natural product extracts; prokinetic agents. [공저자] Physiologically-based pharmacokinetic model for clozapine in Korean patients with schizophrenia 작성자 김민걸 Year 2021 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 69 첨부파일 1 Clozapine has been used as a treatment of schizophrenia. Despite its large interindividual variability, few reports addressed the physiologically-based pharmacokinetic modeling and simulation (PBPK M&S) of clozapine in patients. This study aimed to develop a PBPK M&S of clozapine in Korean patients with schizophrenia. PBPK modeling for clozapine was constructed using a population-based PBPK platform, the SimCYP® Simulator (V19; Certara, Sheffield, UK). The PBPK model was developed by optimizing the physiological parameters of the built-in population and compound libraries in the SimCYP® Simulator. The model verification was performed with the predicted/observed ratio for pharmacokinetic parameters and visual predictive checks (VPCs) plot. Simulations were performed to predict toxicities according to dosing regimens. From published data, 230 virtual trials were simulated for each dosing regimen. The predicted/observed ratio for the area under the curve and peak plasma concentration was calculated to be from 0.78 to 1.34. The observation profiles were within the 5th and 95th percentile range with no serious model misspecification through the VPC plot. A significant impact on age and gender was found for clozapine clearance. The simulation results suggested that 150 mg twice a day and 150 mg three times a day of clozapine have toxicity concerns. In conclusion, a PBPK model was developed and reasonable parameters were made from the data of Korean patients with schizophrenia. The provided model might be used to predict the pharmacokinetics of clozapine and assist dose adjustment in clinical settings.Keywords: Clozapine; Korean; PBPK; Schizophrenia Patients. [교신저자] Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects 작성자 김민걸 Year 2021 Journal Clin Ther 추천 0 비추천 0 조회수 71 첨부파일 1 Purpose: Tegoprazan is a potassium-competitive acid blocker used for gastric acid suppression, which may be used with Helicobacter pylori eradication therapies. The goal of this study was to evaluate the pharmacokinetic interaction between tegoprazan and triple-antibiotic therapy containing metronidazole, tetracycline, and bismuth.Methods: An open-label, 2-cohort, randomized, multiple-dose, crossover study was conducted in healthy subjects. In cohort 1, tegoprazan (100 mg/d) was administered orally with or without triple-antibiotic therapy (1500 mg/d metronidazole, 2000 mg/d tetracycline, and 1200 mg/d bismuth) for 7 days in each period. In cohort 2, triple-antibiotic therapy was administered orally with or without tegoprazan for 7 days in each period. Pharmacokinetic blood samples were collected within 24 h after the last dose. Safety assessments were performed.Findings: Eleven cohort 1 subjects and ten cohort 2 subjects were included in the pharmacokinetic analysis. The AUCτ and Cmax at steady state geometric mean ratios (90% CIs) were 0.78 (0.73-0.83) and 0.75 (0.68-0.82) for tegoprazan; 0.77 (0.68-0.88) and 0.84 (0.72-0.98) for tegoprazan metabolite M1; 1.03 (0.98-1.08) and 1.08 (0.99-1.18) for metronidazole; 0.63 (0.56-0.70) and 0.64 (0.56-0.74) for tetracycline; and 1.55 (0.99-2.44) and 1.38 (0.72-2.66) for bismuth, respectively. All reported adverse events were mild.Implications: Changes in the tegoprazan, tetracycline, and bismuth pharmacokinetic parameters were detected after concurrent administration. These changes were considered mainly due to the pharmacodynamic effect of tegoprazan. The adverse events were predictable and reported as frequent adverse events during triple-antibiotic therapy. There were no significant differences in safety or tolerability between quadruple therapy, including tegoprazan and triple-antibiotic therapy. ClinicalTrials.gov identifier: NCT04066257.Keywords: Helicobacter pylori; bismuth; metronidazole; pharmacokinetic drug interaction; tegoprazan; tetracycline. [공저자] Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects 작성자 김민걸 Year 2021 Journal Clin Transl Sci 추천 0 비추천 0 조회수 49 첨부파일 1 This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC0-inf ); AUC from time zero to the last quantifiable concentration (AUC0-last ); and maximum serum concentration (Cmax ). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC0-inf , AUC0-last , and Cmax were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars. [교신저자] An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men 작성자 김민걸 Year 2020 Journal Clin Ther 추천 0 비추천 0 조회수 33 첨부파일 0 Purpose: Patients with type 2 diabetes mellitus require strict blood glucose control, and combination therapy with a thiazolidinedione and dipeptidyl peptidase-4 inhibitors, such as lobeglitazone and sitagliptin, is one of the recommended treatments. The objective of this study was to investigate a possible pharmacokinetic interaction between lobeglitazone and sitagliptin after multiple oral administrations in healthy Korean men.Methods: Two randomized, open-label, multiple-dose, 2-way crossover studies were conducted simultaneously in healthy men. In study 1, men were randomly assigned to 1 of 2 sequences, and 1 of the following treatments was administered in each period: 1 tablet of lobeglitazone sulfate (0.5 mg) once daily for 5 days and or 1 tablet each of lobeglitazone sulfate (0.5 mg) and sitagliptin (100 mg) once daily for 5 days. In study 2, men were also randomly assigned to 1 of 2 sequences and the treatments were as follows: 1 tablet of sitagliptin (100 mg) once daily for 5 days or 1 tablet each of sitagliptin (100 mg) and lobeglitazone sulfate (0.5 mg) once daily for 5 days. Serial blood samples were collected up to 48 h after dosing on the fifth day. Plasma drug concentrations were measured by LC-MS/MS. Pharmacokinetic parameters, including Cmax,ss and AUC0-τ , were determined by noncompartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% CIs of log-transformed Cmax,ss and AUC0-τ for separate or coadministration were calculated to evaluate pharmacokinetic interactions.Findings: Nineteen men from study 1 and 17 from study 2 completed the pharmacokinetic sampling and were included in the analyses. The GLSM ratios of Cmax,ss and AUC0-τ were 0.9494 (95% CI, 0.8798-1.0243) and 1.0106 (95% CI, 0.9119-1.1198) for lobeglitazone (from study 1) and 1.1694 (95% CI, 1.0740-1.2732) and 1.0037 (95% CI, 0.9715-1.0369) for sitagliptin (from study 2), respectively.Implications: Except for the slight 17% increase in the sitagliptin Cmax,ss value, the pharmacokinetic parameters of lobeglitazone and sitagliptin met the pharmacokinetic equivalent criteria when administered separately or in combination. The increase in Cmax of sitagliptin when coadministered with lobeglitazone would not be clinically significant in practice. ClinicalTrials.gov Identifier: NCT02824874 and NCT02827890.Keywords: Drug–drug interaction; Lobeglitazone; Pharmacokinetics; Phase I; Sitagliptin. [공저자] Is septal deviation associated with headache? A nationwide 10-year follow-up cohort study 작성자 김민걸 Year 2020 Journal Medicine (Baltimore) 추천 0 비추천 0 조회수 29 첨부파일 1 To investigate the potential relationship between septal deviation (SD) and headache using nationwide representative cohort sample data.This study used a nationwide cohort sample from the Korean National Health Insurance Service database. The cohort sample was composed of 1 million patients, which is obtained by propensity score matching from 2002 to 2013. There were 9171 individuals in the SD group and 28243 in the control or no SD group. The Kaplan-Meier survival analysis, the log-rank test, and Cox proportional hazard regression analysis were used to calculate the incidence, survival curve, and hazard ratio of headache for each group.There were no statistically significant differences in sex (P = .7708), age (P = .991), residential area (P = .9626), or socioeconomic status (P = .9982) between the 2 groups. The survival curve between SD and control or no SD showed a statistically significant difference. The adjusted hazard ratio for headache incidence during the 10-year follow-up period of the SD group was 1.37 (95% CI: 1.31-1.43).This cohort study suggests that SD is associated with headache. Therefore, these findings suggest that septoplasty can be considered as 1 of the treatment option in SD patients with headache. [교신저자] Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast an 작성자 김민걸 Year 2020 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 40 첨부파일 0 Objective: Asthma patients often have co-existing symptoms of allergic rhinitis and are often prescribed with both asthma and rhinitis treatments such as montelukast and levocetirizine. The objective of this study was to compare the pharmacokinetic profiles of a montelukast/levocetirizine fixed-dose combination chewable tablet with individual administration of montelukast and levocetirizine in healthy subjects.Materials and methods: A randomized, open-label, single-dose crossover study was conducted in healthy male subjects. One of the following treatments was administered in each period: co-administration of 1 chewable tablet of montelukast 5 mg and 1 tablet of levocetirizine 5 mg or administration of 1 chewable tablet of montelukast/levocetirizine 5/5 mg fixed-dose combination. Serial blood samples were collected up to 48 hours post dose. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry. Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve from dosing to the last measurable concentration (AUClast), were determined by non-compartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% confidence intervals (CIs) of Cmax and AUClast were calculated to evaluate pharmacokinetic equivalence.Results: A total of 22 subjects were included in pharmacokinetic analysis. The GLSM ratios and 90% CIs of Cmax and AUClast were 1.0054 (0.9535 - 1.0601) and 1.0628 (1.0013 - 1.1281) for montelukast and 1.0105 (0.9488 - 1.0764) and 1.0396 (0.9935 - 1.0879) for levocetirizine, respectively.Conclusion: The pharmacokinetic parameters of montelukast and levocetirizine when administered as separate tablets or as a fixed-dose combination were compared, and the parameters met the pharmacokinetic equivalence criteria. (ClinicalTrials.gov Identifier: NCT03371849). [교신저자] SVM-based waist circumference estimation using Kinect 작성자 김민걸 Year 2020 Journal Comput Methods Programs Biomed 추천 0 비추천 0 조회수 28 첨부파일 1 Background and objective: Conventional anthropometric studies using Kinect depth sensors have concentrated on estimating the distances between two points such as height. This paper deals with a novel waist measurement method using SVM regression, further widening spectrum of Kinect's potential applications. Waist circumference is a key index for the diagnosis of abdominal obesity, which has been linked to metabolic syndromes and other related diseases. Yet, the existing measuring method, tape measure, requires a trained personnel and is therefore costly and time-consuming.Methods: A dataset was constructed by recording both 30 frames of Kinect depth image and careful tape measurement of 19 volunteers by a clinical investigator. This paper proposes a new SVM regressor-based approach for estimating waist circumference. A waist curve vector is extracted from a raw depth image using joint information provided by Kinect SDK. To avoid overfitting, a data augmentation technique is devised. The 30 frontal vectors and 30 backside vectors, each sampled for 1 s per person, are combined to form 900 waist curve vectors and a total of 17,100 samples were collected from 19 individuals. On an individual basis, we performed leave-one-out validation using the SVM regressor with the tape measurement-gold standard of waist circumference measurement-values labeled as ground-truth. On an individual basis, we performed leave-one-out validation using the SVM regressor with the tape measurement-gold standard of waist circumference measurement-values labeled as ground-truth.Results: The mean error of the SVM regressor was 4.62 cm, which was smaller than that of the geometric estimation method. Potential uses are discussed.Conclusions: A possible method for measuring waist circumference using a depth sensor is demonstrated through experimentation. Methods for improving accuracy in the future are presented. Combined with other potential applications of Kinect in healthcare setting, the proposed method will pave the way for patient-centric approach of delivering care without laying burdens on patients.Keywords: Machine learning; Support vector machine; Waist measurement. [공저자] Comparative pharmacokinetic and bioavailability studies of monotropein, kaempferol-3-o-glucoside, and quercetin-4-o-glucoside after oral and intraveno 작성자 김민걸 Year 2020 Journal J Mens Health 추천 0 비추천 0 조회수 20 첨부파일 1 Background and Objective This study has evaluated the pharmacokinetic parameters and bioavailabilities of monotropein, kaempferol-3-O-glucoside, and quercetin-4'-O-glucoside after administration of MOTILIPERM in rats. Material and MethodsFollowing the administration of MOTILIPERM, the plasma concentrations of each compound in rats were simultaneously determined by using liquid chromatography tandem mass spectrometry (LC-MS/MS). ResultsThe pharmacokinetic parameters of monotropein in rats were AUC(inf) 20,020.44 +/- 3944.67 and 11,915.53 +/- 1190.91 min.ng/mL and C-max 286.99 +/- 38.37 and 56.23 +/- 9.02 ng/mL for intravenous and oral administration, respectively. The pharmacokinetic parameters of kaempferol-3-O-glucoside in rats were AUC(inf) 287.86 +/- 126.17 min.ng/mL and not estimated; C-max 5.80 +/- 1.87 and 1.24 +/- 0.41 ng/mL for intravenous and oral administration, respectively. The pharmacokinetic parameters of quercetin-4'-O-glucoside in rats were AUC(inf) 511.38 +/- 248.11 and 481.44 +/- 65.72 min.ng/mL; C-max 10.72 +/- 2.70 and 2.83 +/- 0.34 ng/mL for intravenous and oral administration, respectively. ConclusionThe absolute bioavailabilities of monotropein and quercetin-4'-O-glucoside for oral administration were evaluated and calculated as 3.0 and 4.7%, respectively. The absolute bioavailability of kaempferol-3-O-glucoside was not calculated because the elimination rate constant could not be estimated. These results may be applied to the basic data in a further study in order to develop functional foods or herbal medicinal products. [교신저자] Evaluation of the pharmacokinetic interaction between lobeglitazone and dapagliflozin at steady state 작성자 김민걸 Year 2020 Journal Clin Ther 추천 0 비추천 0 조회수 19 첨부파일 0 Purpose: Coadministration of lobeglitazone and dapagliflozin is expected to result in a blood glucose-lowering effect, followed by a gradual increase, in clinical usage; however, combining drugs could cause negative interactions. This study aimed to evaluate the effect of the coadministration of lobeglitazone and dapagliflozin on their individual pharmacokinetic properties at steady state in healthy male volunteers in the fasted state.Methods: This study consisted of 2 parts, each of which was a randomized, open-labeled, multiple-dose, 2-way crossover study in 20 healthy male volunteers in each part. Blood samples were taken periodically over a 48-h period after dosing to derive total plasma lobeglitazone and dapagliflozin pharmacokinetic properties; safety profile was evaluated throughout the study.Findings: When the pharmacokinetic properties of dapagliflozin were evaluated following its administration alone and in combination with lobeglitazone, point estimate and 90% CI of the geometric mean ratio of dapagliflozin AUCτ were entirely within the conventional bioequivalence range of 80%-125%. However, although it was not clinically meaningful, its Css,max was ~8% lower in subjects receiving multiple doses of dapagliflozin and lobeglitazone than that in those administered dapagliflozin alone. The pharmacokinetic properties of lobeglitazone were evaluated following its administration alone and in combination with dapagliflozin. The geometric mean ratios and 90% CIs of the lobeglitazone Css,max and AUCτ were within the conventional bioequivalence range of 80%-125%.Implications: Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug. Based on these findings, it is anticipated that lobeglitazone and dapagliflozin can be coadministered without dose adjustment. ClinicalTrials.gov identifier: NCT03616392.Keywords: Drug-drug interaction; Lobeglitazone; Pharmacokinetics; Type 2 diabetes; dapagliflozin. [공저자] 15d-PGJ2 inhibits NF-κB and AP-1-mediated MMP-9 expression and invasion of breast cancer cell by means of a heme oxygenase-1-dependent mechanism 작성자 김민걸 Year 2020 Journal BMB Rep 추천 0 비추천 0 조회수 19 첨부파일 1 Activation of peroxisome proliferator-activated receptor γ (PPARγ) serves as a key factor in the proliferation and invasion of breast cancer cells and is a potential therapeutic target for breast cancer. However, the mechanisms underlying this effect remain largely unknown. Heme oxygenase-1 (HO-1) is induced and overexpressed in various cancers and is associated with features of tumor aggressiveness. Recent studies have shown that HO-1 is a major downstream target of PPARγ. In this study, we investigated the effects of induction of HO-1 by PPARγ on TPAinduced MMP-9 expression and cell invasion using MCF-7 breast cancer cells. TPA treatment increased NF-κB /AP-1 DNA binding as well as MMP-9 expression. These effects were significantly blocked by 15d-PGJ2, a natural PPARγ ligand. 15d-PGJ2 induced HO-1 expression in a dose-dependent manner. Interestingly, HO-1 siRNA significantly attenuated the inhibition of TPA-induced MMP-9 protein expression and cell invasion by 15d-PGJ2. These results suggest that 15d-PGJ2 inhibits TPA-induced MMP- 9 expression and invasion of MCF-7 cells by means of a heme oxygenase-1-dependent mechanism. Therefore, PPARγ/HO-1 signaling- pathway inhibition may be beneficial for prevention and treatment of breast cancer. [BMB Reports 2020; 53(4): 212-217]. [교신저자] Pharmacokinetic Interaction Among Telmisartan, Amlodipine, and Hydrochlorothiazide After a Single Oral Administration in Healthy Male Subjects 작성자 김민걸 Year 2019 Journal Clin Ther 추천 0 비추천 0 조회수 19 첨부파일 0 Purpose: Hypertension is a major risk factor for cardiovascular diseases, necessitating hypertension control. Antihypertensive drugs are more potent when administered in combinations of 2 or 3 different classes of drugs. One such therapy includes a combination of an angiotensin receptor blocker, a calcium channel blocker, and a diuretic. The objective of this study was to evaluate the pharmacokinetic interaction among telmisartan, amlodipine, and hydrochlorothiazide.Methods: A randomized, open-label, 3-period, 6-sequence, 3-treatment, single-dose crossover study was conducted in healthy male subjects. Subjects were randomly assigned to 1 of 6 sequences and one of the following treatments was administered in each period: treatment A, co-administration of one tablet of telmisartan 80 mg and one tablet of amlodipine 10 mg; treatment B, one tablet of hydrochlorothiazide 25 mg alone; and treatment C, co-administration of all 3 investigational products. Serial blood samples were collected up to 144 hours postdose. Plasma drug concentrations were measured by using LC/MS-MS. Pharmacokinetic parameters, including Cmax and AUC0-last, were determined by using noncompartmental analysis. The geometric least squares mean ratios and associated 90% CIs of log-transformed Cmax and AUC0-last for separate administration or co-administration were calculated to evaluate pharmacokinetic interactions.Findings: Twenty-seven subjects completed the study. The geometric least squares mean ratios and 90% CIs of Cmax and AUC0-last were 1.02 (0.85-1.21) and 1.04 (0.97-1.13) for telmisartan; 1.00 (0.95-1.04) and 0.95 (0.91-0.99) for amlodipine; and 0.88 (0.82-0.96) and 0.86 (0.82-0.90) for hydrochlorothiazide, respectively. No serious adverse events were recorded, and all reported adverse events were of mild intensity.Implications: The pharmacokinetic parameters of telmisartan, amlodipine, and hydrochlorothiazide when administered separately or co-administered were compared, and all the parameters met the criteria for pharmacokinetic equivalence. Combination therapy of these 3 drugs had no significant impact on the pharmacokinetic parameters of each drug. (ClinicalTrials.gov Identifier: NCT03889145).Keywords: Phase I; antihypertensive; drug–drug interaction; pharmacokinetics. [교신저자] Pharmacokinetic and bioequivalence study of a fixed-dose combination of amlodipine besylate and rosuvastatin calcium compared to co-administration of 작성자 김민걸 Year 2019 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 25 첨부파일 0 Context: A fixed-dose combination (FDC) tablet of amlodipine and rosuvastatin was recently developed for the treatment of concomitant hypertension and dyslipidemia and is anticipated to improve medication compliance.Objective: This study was performed to compare the single-dose pharmacokinetic properties and safety of DP-R212 (FDC of amlodipine and rosuvastatin) to those of each agent co-administered in healthy Korean subjects.Materials and methods: A total of 36 healthy Korean subjects were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test drug (FDC tablet containing amlodipine and rosuvastatin) or reference drugs (individual tablets). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours post-dose. Safety was assessed by the evaluation of adverse events (AEs), laboratory assessments, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign measurements.Results: The 90% confidence intervals (CIs) of the geometric least-square mean ratios of AUClast and Cmax were 0.9796 - 1.0590 and 1.0135 - 1.0981 for amlodipine, and 0.9156 - 1.0490 and 0.8400 - 1.0306 for rosuvastatin, respectively. All AEs were of mild to moderate intensity, and no significant difference was observed in the incidence of AEs between the treatments. Moreover, the pharmacokinetic properties of the test and reference drugs were bioequivalent to each other, satisfying the regulatory criteria (0.8 - 1.25).Discussion and conclusion: Both drugs were safe and well tolerated, and the pharmacokinetic profiles were comparable between the treatments. [교신저자] Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects 작성자 김민걸 Year 2019 Journal Drug Des Devel Ther 추천 0 비추천 0 조회수 23 첨부파일 1 Purpose: Hypertension and dyslipidemia are major risk factors for cardiovascular diseases, and reduction of cardiovascular risks can be achieved by combining antihypertensive therapy with statins. The objective of this study was to evaluate the pharmacokinetic interaction between telmisartan/amlodipine fixed dose combination and rosuvastatin in healthy Korean male volunteers.Patients and methods: An open-label, two-cohort, multiple-dose, single-sequence crossover study was conducted in healthy male subjects. In Cohort 1, the subjects were administered one tablet of telmisartan/amlodipine 80 mg/5 mg once daily for 14 days with or without one tablet of rosuvastatin 20 mg once daily. In Cohort 2, the subjects were administered one tablet of rosuvastatin 20 mg once daily for 14 days with or without one tablet of telmisartan/amlodipine 80 mg/5 mg once daily. Serial blood samples were collected up to 24 hrs post-dose on the 9th and 14th days in Cohort 1 and on the 5th and 14th days in Cohort 2. Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry. Pharmacokinetic parameters, including maximum plasma concentration at steady state (Cmax,ss) and area under the plasma concentration versus time curve over dosing interval (AUCτ,ss), were determined by non-compartmental analysis. The geometric least-square mean (GLSM) ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax,ss and AUCτ,ss for separate or concurrent therapy were calculated to evaluate pharmacokinetic interactions.Results: Thirty-eight subjects from Cohort 1 and nineteen subjects from Cohort 2 completed the study. The GLSM ratios and 90% CIs of Cmax,ss and AUCτ,ss, were 0.9829 (0.8334-1.1590) and 1.0003 (0.9342-1.0710) for telmisartan; 0.9908 (0.9602-1.0223) and 1.0081 (0.9758-1.0413) for amlodipine; and 2.2762 (2.0113-2.5758) and 1.3261 (1.2385-1.4198) for rosuvastatin, respectively.Conclusion: The pharmacokinetic parameters of telmisartan/amlodipine, but not rosuvastatin, met the pharmacokinetic equivalent criteria. The increase in systemic exposure to rosuvastatin caused by telmisartan/amlodipine co-administration would not be clinically significant in practice. Nevertheless, an appropriately designed two-sequence crossover study is needed to confirm the results of this study.Keywords: antihypertensive; drug–drug interactions; pharmacokinetics; phase I; statins. [교신저자] Pharmacokinetics of a Lobeglitazone/Metformin Fixed‐Dose Combination Tablet (CKD‐395 0.5/1000 mg) Versus Concomitant Administration of Single Agents a 작성자 김민걸 Year 2019 Journal Clin Pharmacol Drug Dev 추천 0 비추천 0 조회수 24 첨부파일 0 This study aimed to compare the pharmacokinetic profile of combined CKD-395 0.5/1000 mg treatment with that of the coadministration of lobeglitazone sulfate 0.5 mg and metformin hydrochloride (HCl) extended-release (XR) 1000 mg and assess the effect of food on the pharmacokinetics of CKD-395 0.5/1000 mg. Two clinical trials were conducted as part of an open-label, single-dose, randomized, 2-period, 2-sequence crossover study. In study 1, a total of 26 subjects received either CKD-395 0.5/1000 mg as a test drug or coadministration of lobeglitazone sulfate 0.5 mg and metformin HCl XR 1000 mg individually as a reference treatment under fed conditions. In study 2, a total of 16 subjects received CKD-395 0.5/1000 mg treatment under either fasted or fed conditions. Blood samples were collected at intervals from 0 to 48 hours. In study 1, the geometric mean ratios and 90% confidence intervals of pharmacokinetic parameters for lobeglitazone and metformin were all within 80%-125% in the fed condition. In study 2, there were no high-fat meal effects on the area under the curve extending up to the last sampling time (AUClast ) of lobeglitazone, but there was a decrease in the maximum plasma concentration (Cmax ) of lobeglitazone by approximately 32% in the fed condition. Although the AUClast of metformin increased by approximately 70% in the fed condition, there was no effect of food on the Cmax of metformin, which is consistent with the already-established food effect on metformin HCl XR. No adverse drug reactions or serious adverse events were observed. This study suggests that CKD-395 0.5/1000 mg exhibits similar exposure and absorption rates to coadministration of single agents and is well tolerated under both fasted and fed conditions.Keywords: fixed-dose combination (FDC); food effect; lobeglitazone; metformin; pharmacokinetics. [공저자] Physiological Change of Serum Bilirubin Level by ω -3 Enriched Parenteral Nutrition Versus ω -3 Free Parenteral Nutrition in Healthy Male Subjects 작성자 김민걸 Year 2019 Journal Surg Metab Nutr 추천 0 비추천 0 조회수 21 첨부파일 1 Purpose:Bilirubin is a biomarker for the diagnosis of liver diseases or bile duct dysfunction. This study assessed the physiological changes in the blood bilirubin level infusing ω-3 enriched parenteral nutrition (PN) and ω-3 free PN in healthy male subjects.Materials and Methods:This study was a randomized, open-label, two-treatment, two-way crossover trial. Sixteen subjects were assigned randomly to one of two sequences of the two treatments: ω-3 enriched PN or ω-3 free PN was infused via aperipheral venous catheter for six hours at 3 mL/kg/h. Blood samples were collected every one hour from 0 to 12 hours after starting an intravenous infusion for bilirubin concentrations. The total bilirubin and direct bilirubin concentrations in the blood were analyzed using an enzymatic method.Results:The bilirubin concentration in the blood was reduced while infusing the ω-3 enriched PN and ω-3 free PN. When it stopped infusing, the bilirubin concentration was recovered. A similar pattern was observed, but there was a further decline and recovery in ω-3 free PN.Conclusion:When ω-3 enriched PN and ω-3 free PN are infused in healthy male subjects, the blood bilirubin level decreasedand there is no difference between the two groups.Keywords : Parenteral nutrition, Omega-3, Bilirubin, Liver disease [교신저자] Comparison of pharmacokinetic characteristics of two Tegoprazan (CJ-12420) formulations in healthy male subjects 작성자 김민걸 Year 2019 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 18 첨부파일 1 Proton-pump inhibitors (PPIs) are effectively used to treat acid-related diseases, including gastroesophageal reflux disease (GERD); however, many unmet medical needs still exist. As a new treatment option, potassium-competitive acid blockers (P-CABs), such as tegoprazan, have been developed. This study was performed to compare the pharmacokinetics (PKs) between two formulations (test and reference drugs) of tegoprazan 100 mg tablets. A randomized, single oral dose, two-treatment, two-period, two-sequence study was conducted with 12 healthy subjects. Each subject received the test drug or reference drug in the first period and the alternative treatment in the second period. For PK evaluation, blood samples were collected up to 48 hours post-dose in each period. The plasma concentrations of tegoprazan and its active metabolite (M1) were measured by liquid chromatography-tandem mass spectrometry. PK parameters, including maximum plasma concentration (Cmax) and area under the concentration-time curve from zero to the last measurable time (AUClast), were estimated using a non-compartmental method. The plasma concentration-time profiles of the two formulations were comparable. The geometric mean ratios [90% confidence intervals (CIs)] of the test drug to the reference drug for Cmax and AUClast were 0.98 (0.85-1.12) and 1.03 (0.93-1.13), respectively. The corresponding values of M1 were 0.99 (0.89-1.11) and 1.01 (0.93-1.09), respectively. The two formulations of tegoprazan exhibited comparable PK profiles, fulfilling the regulatory criteria for bioequivalence.Keywords: Bioequivalence; Clinical trial; Pharmacokinetics; Phase 1. [교신저자] Introduction to in silico model for proarrhythmic risk assessment under the CiPA initiative 작성자 김민걸 Year 2019 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 22 첨부파일 1 In 2005, the International Council for Harmonization (ICH) established cardiotoxicity assessment guidelines to identify the risk of Torsade de Pointes (TdP). It is focused on the blockade of the human ether-à-go-go-related gene (hERG) channel known to cause QT/QTc prolongation and the QT/QTc prolongation shown on the electrocardiogram. However, these biomarkers are not the direct risks of TdP with low specificity as the action potential is influenced by multiple channels along with the hERG channel. Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative emerged to address limitations of the current model. The objective of CiPA is to develop a standardized in silico model of a human ventricular cell to quantitively evaluate the cardiac response for the cardiac toxicity risk and to come up with a metric for the TdP risk assessment. In silico working group under CiPA developed a standardized and reliable in silico model and a metric that can quantitatively evaluate cellular cardiac electrophysiologic activity. The implementation mainly consists of hERG fitting, Hill fitting, and action potential simulation. In this review, we explained how the in silico model of CiPA works, and briefly summarized current overall CiPA studies. We hope this review helps clinical pharmacologists to understand the underlying estimation process of CiPA in silico modeling.Keywords: Cardiotoxicity; CiPA; Torsade de Pointes. [교신저자] Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male 작성자 김민걸 Year 2018 Journal Clin Ther 추천 0 비추천 0 조회수 17 첨부파일 0 Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers [교신저자] Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, singl 작성자 김민걸 Year 2018 Journal Drug Des Devel Ther 추천 0 비추천 0 조회수 20 첨부파일 0 Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study [공저자] Pharmacokinetics and bioequivalence of 0.5 mg lobeglitazone tablets in healthy male subjects 작성자 김민걸 Year 2018 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 21 첨부파일 0 Pharmacokinetics and bioequivalence of 0.5 mg lobeglitazone tablets in healthy male subjects [공저자] Effect of green tea catechins on the pharmacokinetics of digoxin in humans 작성자 김민걸 Year 2018 Journal Drug Des Devel Ther 추천 0 비추천 0 조회수 31 첨부파일 0 Effect of green tea catechins on the pharmacokinetics of digoxin in humans [교신저자] The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System 작성자 김민걸 Year 2018 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 45 첨부파일 0 The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System [교신저자] Pharmacokinetics comparison of solifenacin tartrate and solifenacin succinate: A randomized, open-label, single-dose, 2-way crossover study in healthy 작성자 김민걸 Year 2018 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 41 첨부파일 0 Pharmacokinetics comparison of solifenacin tartrate and solifenacin succinate: A randomized, open-label, single-dose, 2-way crossover study in healthy male volunteers [공저자] Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet 작성자 김민걸 Year 2018 Journal Drug Des Devel Ther 추천 0 비추천 0 조회수 16 첨부파일 0 Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet Quantitative analysis of acetylsalicylic acid in human blood using volumetric absorptive microsampling 작성자 김민걸 Year 2018 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 37 첨부파일 0 Quantitative analysis of acetylsalicylic acid in human blood using volumetric absorptive microsampling [교신저자] Pharmacokinetics of fixed-dose combination of rosuvastatin 20 mg and ezetimibe 10 mg compared to concurrent administration of individual tablets in he 작성자 김민걸 Year 2018 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 22 첨부파일 0 Pharmacokinetics of fixed-dose combination of rosuvastatin 20 mg and ezetimibe 10 mg compared to concurrent administration of individual tablets in healthy Korean subjects Acceptance rate of long-acting injection after short information: A survey in patients with first- and multiple-episode psychoses and their caregivers 작성자 김민걸 Year 2017 Journal Early Intervention in Psychiatry 추천 0 비추천 0 조회수 16 첨부파일 0 Acceptance rate of long-acting injection after short information: A survey in patients with first- and multiple-episode psychoses and their caregivers Associations of fatty acids with cognition, psychopathology, and brain-derived neurotrophic factor levels in patients with first-episode schizophrenia 작성자 김민걸 Year 2017 Journal J Psychopharmacol 추천 0 비추천 0 조회수 14 첨부파일 0 Associations of fatty acids with cognition, psychopathology, and brain-derived neurotrophic factor levels in patients with first-episode schizophrenia and related disorders treated with paliperidone extended release Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects 작성자 김민걸 Year 2017 Journal Clin Pharmacol Drug Dev 추천 0 비추천 0 조회수 16 첨부파일 0 Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects Phase I and Pharmacokinetic Drug-Drug Interaction Study of Metformin, Losartan, and Linagliptin Coadministered with DW1029M in Healthy Volunteers 작성자 김민걸 Year 2017 Journal Clin Pharmacol Drug Dev 추천 0 비추천 0 조회수 15 첨부파일 0 Phase I and Pharmacokinetic Drug-Drug Interaction Study of Metformin, Losartan, and Linagliptin Coadministered with DW1029M in Healthy Volunteers Effect of epigallocatechin-3-gallate, major ingredient of green tea, on the pharmacokinetics of rosuvastatin in healthy volunteers 작성자 김민걸 Year 2017 Journal Drug Des Devel Ther 추천 0 비추천 0 조회수 15 첨부파일 0 Effect of epigallocatechin-3-gallate, major ingredient of green tea, on the pharmacokinetics of rosuvastatin in healthy volunteers Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administra 작성자 김민걸 Year 2017 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 16 첨부파일 0 Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects Effect of fermented Red ginseng on cytochrome P450 and P-glycoprotein activity in healthy subjects, as evaluated using the cocktail approach 작성자 김민걸 Year 2016 Journal Br J Clin Pharmacol 추천 0 비추천 0 조회수 18 첨부파일 0 Effect of fermented Red ginseng on cytochrome P450 and P-glycoprotein activity in healthy subjects, as evaluated using the cocktail approach Effect of Modulated Electrohyperthermia on the Pharmacokinetics of Oral Transmucosal Fentanyl Citrate in Healthy Volunteers 작성자 김민걸 Year 2016 Journal Clin Ther 추천 0 비추천 0 조회수 36 첨부파일 0 Effect of Modulated Electrohyperthermia on the Pharmacokinetics of Oral Transmucosal Fentanyl Citrate in Healthy Volunteers Changes in the Ginsenoside Content During Fermentation Using an Appliance for the Preparation of Red Ginseng 작성자 김민걸 Year 2016 Journal Am J Chin Med 추천 0 비추천 0 조회수 22 첨부파일 0 Changes in the Ginsenoside Content During Fermentation Using an Appliance for the Preparation of Red Ginseng Effect of Red Ginseng on Cytochrome P450 and P-glycoprotein Activities in Healthy Volunteers 작성자 김민걸 Year 2016 Journal J Ginseng Res 추천 0 비추천 0 조회수 15 첨부파일 0 Effect of Red Ginseng on Cytochrome P450 and P-glycoprotein Activities in Healthy Volunteers Early predictors of a clinical response at 8 weeks in patients with first-episode psychosis treated with paliperidone ER 작성자 김민걸 Year 2016 Journal J Psychopharmacol 추천 0 비추천 0 조회수 34 첨부파일 0 Early predictors of a clinical response at 8 weeks in patients with first-episode psychosis treated with paliperidone ER Population pharmacokinetics of aripiprazole in healthy Korean subjects 작성자 김민걸 Year 2016 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 15 첨부파일 0 Population pharmacokinetics of aripiprazole in healthy Korean subjects HPLC-UV method for the simultaneous determinations of ascorbic acid and dehydroascorbic acid in human plasma 작성자 김민걸 Year 2016 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 15 첨부파일 0 HPLC-UV method for the simultaneous determinations of ascorbic acid and dehydroascorbic acid in human plasma Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-Aged Korean Subj 작성자 김민걸 Year 2015 Journal Clin Ther 추천 0 비추천 0 조회수 19 첨부파일 0 Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-Aged Korean Subjects Rice-based Korean meals (bibimbap and kimbap) have lower glycemic responses and postprandial-triglyceride effects than energy-matched Western meals 작성자 김민걸 Year 2015 Journal J Ethn Foods 추천 0 비추천 0 조회수 16 첨부파일 0 Rice-based Korean meals (bibimbap and kimbap) have lower glycemic responses and postprandial-triglyceride effects than energy-matched Western meals Simultaneous determination of L-ascorbic acid and dehydroascorbic acid in human plasma 작성자 김민걸 Year 2015 Journal Anal Methods 추천 0 비추천 0 조회수 24 첨부파일 0 Simultaneous determination of L-ascorbic acid and dehydroascorbic acid in human plasma Changes in the ginsenoside content during the fermentation process using microbial strains 작성자 김민걸 Year 2015 Journal J Ginseng Res 추천 0 비추천 0 조회수 27 첨부파일 0 Changes in the ginsenoside content during the fermentation process using microbial strains Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): A randomized, double-blind, placebo-controlled clinical trial 작성자 김민걸 Year 2015 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 32 첨부파일 0 Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): A randomized, double-blind, placebo-controlled clinical trial R-based reproduction of the estimation process hidden behind NONMEM® Part 1: First-order approximation method 작성자 김민걸 Year 2015 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 25 첨부파일 0 R-based reproduction of the estimation process hidden behind NONMEM® Part 1: First-order approximation method Effect of Chongkukjang on histamine-induced skin wheal response: Randomized, double-blind, placebo-controlled trial 작성자 김민걸 Year 2015 Journal J Ethn Foods 추천 0 비추천 0 조회수 16 첨부파일 0 Effect of Chongkukjang on histamine-induced skin wheal response: Randomized, double-blind, placebo-controlled trial What Do Very Low Plasma Concentrations of High-sensitivity C-reactive Protein (hs-CRP) Mean among Healthy Middle-aged Koreans 작성자 김민걸 Year 2015 Journal J Lifestyle Med 추천 0 비추천 0 조회수 15 첨부파일 0 What Do Very Low Plasma Concentrations of High-sensitivity C-reactive Protein (hs-CRP) Mean among Healthy Middle-aged Koreans The effect of modulated electro-hyperthermia on the pharmacokinetic properties of nefopam in healthy volunteers: A randomised, single-dose, crossover 작성자 김민걸 Year 2015 Journal Int J Hyperthermia 추천 0 비추천 0 조회수 14 첨부파일 0 The effect of modulated electro-hyperthermia on the pharmacokinetic properties of nefopam in healthy volunteers: A randomised, single-dose, crossover open-label study An Assessment of the Pharmacokinetics of a Sustained-Release Formulation of a Tramadol/Acetaminophen Combination in Healthy Subjects 작성자 김민걸 Year 2015 Journal Clin Ther 추천 0 비추천 0 조회수 15 첨부파일 0 An Assessment of the Pharmacokinetics of a Sustained-Release Formulation of a Tramadol/Acetaminophen Combination in Healthy Subjects Pharmacokinetic properties of isosorbide-5- mononitrate under fasting and fed conditions in healthy male subjects 작성자 김민걸 Year 2015 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 16 첨부파일 0 Pharmacokinetic properties of isosorbide-5- mononitrate under fasting and fed conditions in healthy male subjects Pharmacokinetic Comparison Study of a Combination Containing 500 mg of Naproxen and 20 mg of Esomeprazole: A Randomized, Single-Dose, 2-Way Crossover, 작성자 김민걸 Year 2015 Journal Clin Ther 추천 0 비추천 0 조회수 19 첨부파일 0 Pharmacokinetic Comparison Study of a Combination Containing 500 mg of Naproxen and 20 mg of Esomeprazole: A Randomized, Single-Dose, 2-Way Crossover, Open-Label Study in Healthy Korean Men Pharmacokinetic Properties of Two Erlotinib 150 mg Formulations with a Genetic Effect Evaluation in Healthy Korean Subjects 작성자 김민걸 Year 2015 Journal Clin Drug Investig 추천 0 비추천 0 조회수 20 첨부파일 0 Pharmacokinetic Properties of Two Erlotinib 150 mg Formulations with a Genetic Effect Evaluation in Healthy Korean Subjects Single-Dose, Randomized, Open-Label, 2-Way Crossover Study of the Pharmacokinetics of Amitriptyline Hydrochloride 10- and 25-mg Tablet in Healthy Male 작성자 김민걸 Year 2015 Journal Clin Ther 추천 0 비추천 0 조회수 18 첨부파일 0 Single-Dose, Randomized, Open-Label, 2-Way Crossover Study of the Pharmacokinetics of Amitriptyline Hydrochloride 10- and 25-mg Tablet in Healthy Male Korean Volunteers An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract 작성자 김민걸 Year 2014 Journal J Ginseng Res 추천 0 비추천 0 조회수 18 첨부파일 0 An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract Pharmacokinetics of a new orally soluble film formulation of sildenafil administered without water 작성자 김민걸 Year 2014 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 42 첨부파일 0 Pharmacokinetics of a new orally soluble film formulation of sildenafil administered without water Beneficial Effects of Korean Traditional Diets in Hypertensive and Type 2 Diabetic Patients 작성자 김민걸 Year 2014 Journal J Med Food 추천 0 비추천 0 조회수 33 첨부파일 0 Beneficial Effects of Korean Traditional Diets in Hypertensive and Type 2 Diabetic Patients Pharmacokinetic Characteristics of Ibandronate and Tolerability of DP-R206 (150 mg Ibandronate/24,000 IU Vitamin D3) Compared to the Ibandronate (150 작성자 김민걸 Year 2014 Journal Transl Clin Pharmacol 추천 0 비추천 0 조회수 15 첨부파일 0 Pharmacokinetic Characteristics of Ibandronate and Tolerability of DP-R206 (150 mg Ibandronate/24,000 IU Vitamin D3) Compared to the Ibandronate (150 mg) Monotherapy in Healthy Adults Comparison of the Pharmacokinetics, Safety, and Tolerability of Vitamin D3 in DP-R206 (150-mg Ibandronate/24,000-IU Vitamin D3 Tablet) and as Monother 작성자 김민걸 Year 2014 Journal Clin Ther 추천 0 비추천 0 조회수 21 첨부파일 0 Comparison of the Pharmacokinetics, Safety, and Tolerability of Vitamin D3 in DP-R206 (150-mg Ibandronate/24,000-IU Vitamin D3 Tablet) and as Monotherapy (24,000 IU) in Healthy Male Korean Adults Pharmacokinetic comparisons between two formulations containing 100 mg of miglitol in healthy Korean male volunteers: A randomized, open-label, single 작성자 김민걸 Year 2014 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 26 첨부파일 0 Pharmacokinetic comparisons between two formulations containing 100 mg of miglitol in healthy Korean male volunteers: A randomized, open-label, single-dose, two-period, twosequence crossover bioequivalence study Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects 작성자 김민걸 Year 2013 Journal Int J Clin Pharmacol Ther 추천 0 비추천 0 조회수 15 첨부파일 0 Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: Study protocol 작성자 김민걸 Year 2013 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 18 첨부파일 0 The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: Study protocol Validation of LC-MS/MS method for determination of ginsenoside Rg1 in human plasma 작성자 김민걸 Year 2013 Journal Anal Sci Technol 추천 0 비추천 0 조회수 18 첨부파일 0 Validation of LC-MS/MS method for determination of ginsenoside Rg1 in human plasma The effect of udenafil on the hemodynamics of healthy male volunteers administered tamsulosin 작성자 김민걸 Year 2013 Journal Curr Med Res Opin 추천 0 비추천 0 조회수 41 첨부파일 0 The effect of udenafil on the hemodynamics of healthy male volunteers administered tamsulosin Comparative Proteomic Tissue Analysis in Patients with Ossification of the Posterior Longitudinal Ligament 작성자 김민걸 Year 2013 Journal World Neurosurg 추천 0 비추천 0 조회수 15 첨부파일 0 Comparative Proteomic Tissue Analysis in Patients with Ossification of the Posterior Longitudinal Ligament The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: A randomised controlled study 작성자 김민걸 Year 2013 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 17 첨부파일 0 The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: A randomised controlled study Development and validation of an LC-MS/MS method for determination of compound K in human plasma and clinical application 작성자 김민걸 Year 2013 Journal J Ginseng Res 추천 0 비추천 0 조회수 17 첨부파일 0 Development and validation of an LC-MS/MS method for determination of compound K in human plasma and clinical application Kochujang, fermented soybean-based red pepper paste, decreases visceral fat and improves blood lipid profiles in overweight adults 작성자 김민걸 Year 2013 Journal Nutr Metab (Lond) 추천 0 비추천 0 조회수 34 첨부파일 0 Kochujang, fermented soybean-based red pepper paste, decreases visceral fat and improves blood lipid profiles in overweight adults Confirmation of Schizandrin as a Marker Compound in Jangsu Omija Powder 작성자 김민걸 Year 2013 Journal J Korean Soc Food Sci Nutr 추천 0 비추천 0 조회수 21 첨부파일 0 Confirmation of Schizandrin as a Marker Compound in Jangsu Omija Powder Validation of the LC-MS/MS Method for Ginsenoside Rb1 Analysis in Human Plasma 작성자 김민걸 Year 2012 Journal J Korean Soc Food Sci Nutr 추천 0 비추천 0 조회수 16 첨부파일 0 Validation of the LC-MS/MS Method for Ginsenoside Rb1 Analysis in Human Plasma Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste 작성자 김민걸 Year 2012 Journal Nutr Res Pract 추천 0 비추천 0 조회수 24 첨부파일 0 Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste Preventive Effect of Korean Red Ginseng for Acute Respiratory Illness: A Randomized and Double-Blind Clinical Trial 작성자 김민걸 Year 2012 Journal J Korean Med Sci 추천 0 비추천 0 조회수 17 첨부파일 0 Preventive Effect of Korean Red Ginseng for Acute Respiratory Illness: A Randomized and Double-Blind Clinical Trial Cognitive Effects of a Single Dose of Atypical Antipsychotics in Healthy Volunteers Compared With Placebo or Haloperidol 작성자 김민걸 Year 2012 Journal J Clin Psychopharmacol 추천 0 비추천 0 조회수 16 첨부파일 0 Cognitive Effects of a Single Dose of Atypical Antipsychotics in Healthy Volunteers Compared With Placebo or Haloperidol Method Development of Ellagic Acid as Marker Compound for Standardization of Gochang Bokbunja (Rubus coreanus Miquel) as Functional Ingredient 작성자 김민걸 Year 2012 Journal J Korean Soc Food Sci Nutr 추천 0 비추천 0 조회수 43 첨부파일 0 Method Development of Ellagic Acid as Marker Compound for Standardization of Gochang Bokbunja (Rubus coreanus Miquel) as Functional Ingredient Pharmacokinetic Properties and Bioequivalence of Candesartan Cilexetil in Korean Healthy Volunteers 작성자 김민걸 Year 2012 Journal Drug Dev Ind Pharm 추천 0 비추천 0 조회수 42 첨부파일 0 Pharmacokinetic Properties and Bioequivalence of Candesartan Cilexetil in Korean Healthy Volunteers Rubus coreanus Inhibits Oxidized-LDL Uptake by Macrophages Through Regulation of JNK Activation 작성자 김민걸 Year 2012 Journal Am J Chin Med 추천 0 비추천 0 조회수 38 첨부파일 0 Rubus coreanus Inhibits Oxidized-LDL Uptake by Macrophages Through Regulation of JNK Activation Efficacy and safety of ziprasidone in the treatment of first-episode psychosis: An 8-week, open-label, multicenter trial 작성자 김민걸 Year 2012 Journal Int Clin Psychopharmacol 추천 0 비추천 0 조회수 17 첨부파일 0 Efficacy and safety of ziprasidone in the treatment of first-episode psychosis: An 8-week, open-label, multicenter trial Hypoglycemic Effect of Smallanthus sonchifolius (Yacon) Extracts on Animals with Streptozotocin-induced Diabetes 작성자 김민걸 Year 2012 Journal J Korean Soc Food Sci Nutr 추천 0 비추천 0 조회수 35 첨부파일 0 Hypoglycemic Effect of Smallanthus sonchifolius (Yacon) Extracts on Animals with Streptozotocin-induced Diabetes Effects of male silkworm pupa powder on the erectile dysfunction by chronic ethanol consumption in rats 작성자 김민걸 Year 2012 Journal Lab Anim Res 추천 0 비추천 0 조회수 17 첨부파일 0 Effects of male silkworm pupa powder on the erectile dysfunction by chronic ethanol consumption in rats Different safety profiles of risperidone and paliperidone extended-release: A double-blind, placebo-controlled trial with healthy volunteers 작성자 김민걸 Year 2012 Journal Hum Psychopharmacol 추천 0 비추천 0 조회수 20 첨부파일 0 Different safety profiles of risperidone and paliperidone extended-release: A double-blind, placebo-controlled trial with healthy volunteers Rapid and Sensitive Analysis of Valproic Acid in Human Red Blood Cell by LC-MS/MS 작성자 김민걸 Year 2012 Journal Bull Korean Chem Soc 추천 0 비추천 0 조회수 61 첨부파일 0 Rapid and Sensitive Analysis of Valproic Acid in Human Red Blood Cell by LC-MS/MS Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers 작성자 김민걸 Year 2012 Journal Kor J Clin Pharm 추천 0 비추천 0 조회수 24 첨부파일 0 Pharmacokinetic Properties and Bioequivalence of Cefcapene Pivoxil Hydrochloride 75 mg in Korean Healthy Volunteers Anti-obesity and anti-diabetic effects of Yerba Mate (Ilex paraguariensis) in C57BL/6J mice fed a high-fat diet 작성자 김민걸 Year 2012 Journal Lab Anim Res 추천 0 비추천 0 조회수 20 첨부파일 0 Anti-obesity and anti-diabetic effects of Yerba Mate (Ilex paraguariensis) in C57BL/6J mice fed a high-fat diet Effects of Ficus carica paste on loperamide-induced constipation in rats 작성자 김민걸 Year 2012 Journal Food Chem Toxicol 추천 0 비추천 0 조회수 28 첨부파일 0 Effects of Ficus carica paste on loperamide-induced constipation in rats A placebo-controlled trial of Korean red ginseng extract for preventing Influenza-like illness in healthy adults 작성자 김민걸 Year 2012 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 43 첨부파일 0 A placebo-controlled trial of Korean red ginseng extract for preventing Influenza-like illness in healthy adults Validation of LC-MS/MS method for determination of ertapenem in human plasma and urine 작성자 김민걸 Year 2012 Journal Anal Sci Technol 추천 0 비추천 0 조회수 31 첨부파일 0 Validation of LC-MS/MS method for determination of ertapenem in human plasma and urine Gastrodia elata Blume and its pure compounds protect BV-2 microglial-derived cell lines against β-amyloid: The involvement of GRP78 and CHOP 작성자 김민걸 Year 2012 Journal Biol Res 추천 0 비추천 0 조회수 19 첨부파일 0 Gastrodia elata Blume and its pure compounds protect BV-2 microglial-derived cell lines against β-amyloid: The involvement of GRP78 and CHOP Influence of the Chungkookjang on histamine-induced wheal and flare skin response: A randomized, double-blind, placebo controlled trial 작성자 김민걸 Year 2011 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 40 첨부파일 0 Influence of the Chungkookjang on histamine-induced wheal and flare skin response: A randomized, double-blind, placebo controlled trial Improving Effects of Multigrain Feed on Endurance 작성자 김민걸 Year 2011 Journal J Korean Soc Food Sci Nutr 추천 0 비추천 0 조회수 17 첨부파일 0 Improving Effects of Multigrain Feed on Endurance Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study 작성자 김민걸 Year 2011 Journal Kor J Clin Pharm 추천 0 비추천 0 조회수 31 첨부파일 0 Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study Effects of Ficus carica paste on constipation induced by a high-protein feed and movement restriction in beagles 작성자 김민걸 Year 2011 Journal Lab Anim Res 추천 0 비추천 0 조회수 22 첨부파일 0 Effects of Ficus carica paste on constipation induced by a high-protein feed and movement restriction in beagles Pharmacokinetic Propertiese of Entecavir 1mg in Korean Healthy Volunteers 작성자 김민걸 Year 2011 Journal Kor J Clin Pharm 추천 0 비추천 0 조회수 30 첨부파일 0 Pharmacokinetic Propertiese of Entecavir 1mg in Korean Healthy Volunteers Pharmacokinetic profiles of ceftazidime after intravenous administration in patients undergoing automated peritoneal dialysis 작성자 김민걸 Year 2011 Journal Antimicrob Agents Chemother 추천 0 비추천 0 조회수 34 첨부파일 0 Pharmacokinetic profiles of ceftazidime after intravenous administration in patients undergoing automated peritoneal dialysis Effects of Chungkookjang supplementation on obesity and atherosclerotic indices in overweight/obese subjects: a 12-week, randomized, double-blind, pla 작성자 김민걸 Year 2011 Journal J Med Food 추천 0 비추천 0 조회수 16 첨부파일 0 Effects of Chungkookjang supplementation on obesity and atherosclerotic indices in overweight/obese subjects: a 12-week, randomized, double-blind, placebo-controlled clinical trial [공저자] The Correlation and Accuracy of Glucose Levels between Interstitial Fluid and Venous Plasma by Continuous Glucose Monitoring System 작성자 김민걸 Year 2010 Journal Korean Diabetes J 추천 0 비추천 0 조회수 25 첨부파일 1 Background: Clinical experience with the continuous glucose monitoring systems (CGMS) is limited in Korea. The objective of this study is to evaluate the accuracy of the CGMS and the correlation between interstitial fluid and venous plasma glucose level in Korean healthy male subjects.Methods: Thirty-two subjects were served with glucose solution contained same amount of test food’s carbohydrate and test foods after separate overnight fasts. CGMS was performed over 3 days during hopitalization for each subjects. Venous plasma glucose measurements were carried out during 4 hours (0, 0.25, 0.5, 0.75, 1, 2, 4 hours) just before and after glucose solution and test food load. The performance of the CGMS was evaluated by comparing its readings to those obtained at the same time by the hexokinase method using the auto biochemistry machine (Hitachi 7600-110). Also, correlations between glucose recorded with CGMS and venous plasma glucose value were examined.Results: CGMS slightly underestimated the glucose value as compared with the venous plasma glucose level (16.3 ± 22.2 mg/dL). Correlation between CGMS and venous plasma glucose values throughout sensor lifetime is 0.73 (regression analysis: slope = 1.08, intercept = 8.38 mg/dL). Sensor sensitivity can deteriorate over time, with correlations between venous blood glucose and CGMS values dropping from 0.77 during 1st day to 0.65 during 2nd and 3rd day.Conclusion: The accuracy of data provided by CGMS may be less than expected. CGMS sensor sensitivity is decreased with the passage of time. But, from this study, CGMS can be used for glucose variability tendency monitoring conveniently to the Korean. [공저자] Pharmacodynamic (hemodynamic) and pharmacokinetic comparisons of S-amlodipine gentisate and racemate amlodipine besylate in healthy Korean male volunt 작성자 김민걸 Year 2010 Journal Clin Ther 추천 0 비추천 0 조회수 52 첨부파일 1 Background: S-amlodipine gentisate, consisting entirely of the (S)-enantiomer, was developed to increase the potency and improve the safety profile of amlodipine. Regulatory requirements for marketing of S-amlodipine gentisate in Korea require comparison of this agent versus amlodipine racemate.Objective: This study was conducted to compare the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics of the S-amlodipine formulation (S-amlodipine gentisate) and amlodipine racemate (amlodipine besylate).Methods: This study consisted of 2 separate substudies; PD and PK parameters were evaluated separately. Both studies were conducted using a doubleblind, randomized, 2-period, 2-treatment, 2-sequence, double-dummy, single-dose crossover design with S-amlodipine 5 mg and amlodipine racemate 10 mg, separated by a 2-week washout period. Blood pressure (BP) and heart rate were measured in the sitting position before dosing and at 1, 2, 4, 5, 6, 7, 8, 10, 12, 14, 24, 48, and 72 hours after oral administration of S-amlodipine or amlodipine racemate. Impedance cardiography parameters (stroke volume, cardiac index, and systemic vascular resistance) were measured before and at 1, 2, 4, 5, 6, 7, 8, 10, and 12 hours after dosing. For PK assessments, serial blood samples were collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 144, and 168 hours after dosing, and drug concentrations were determined by HPLC-MS/MS. Adverse events (AEs) were collected using self-report or general health-related questions.Results: The PD study included 24 healthy men (mean [SD] age, 23.1 [3.1] years; weight, 69.2 [6.1] kg), and the PK study included 24 different healthy men (mean age, 25.1 [2.1] years; weight, 65.9 [5.9] kg). There were no statistically significant differences between the treatment groups in terms of systolic BP, diastolic BP, or heart rate by repeated-measures ANOVA. Likewise, in the analysis of impedance cardiography, the treatment groups did not display any significant differences in stroke volume, cardiac index, or systemic vascular resistance by repeatedmeasures ANOVA. The mean (SD) AUC(0-last) was 129.7 (62.8) ng . h/mL after dosing with S-amlodipine and 129.0 (59.6) ng . h/mL after dosing with amlodipine racemate. The geometric mean ratio (S-amlodipine: amlodipine racemate) of the S-amlodipine AUC(0-last) was 1.01 (90% CI, 0.90-1.13). In the PD study, 4 AEs in 3 volunteers (3/24; 12.5%) and 8 AEs in 5 volunteers (5/24; 20.8%) were reported after dosing with S-amlodipine and amlodipine racemate, respectively. In the PK study, 18 AEs in 11 volunteers (11/24; 45.8%) and 20 AEs in 9 volunteers (9/24; 37.5%) were reported after dosing with S-amlodipine and amlodipine racemate, respectively. Five volunteers reported AEs after dosing with both S-amlodipine and amlodipine racemate. For the PD and PK studies combined, 30 AEs were judged to be possibly related to S-amlodipine (16 cases) or amlodipine racemate (14 cases). Twenty AEs were judged not to be related to S-amlodipine (6 cases) or amlodipine racemate (14 cases). The most common AEs considered at least possibly related to the study drug in both studies were headache (18 cases) and nausea (3 cases).Conclusions: In these single-dose studies, no significant differences were found in PD (hemodynamic) or PK parameters between S-amlodipine 5 mg and amlodipine racemate 10 mg. S-amlodipine had a safety profile comparable to that of amlodipine racemate in these healthy male volunteers. [공저자] The Incidence and Clinical Course of Acute Renal Failure in Patients with Severe Acute Pancreatitis 작성자 김민걸 Year 2009 Journal Korean J Nephrol 추천 0 비추천 0 조회수 18 첨부파일 1 PURPOSE:Although acute renal failure (ARF) commonly develops in patients with severe acute pancreatitis (SAP), the impact of ARF on disease severity is rarely reported in Korea. This study was performed to compare the clinical findings, morbidity and mortality between SAP patients with and without ARF.METHODS:We retrospectively evaluated the medical records of 102 patients with SAP between january 2001 and June 2008 in 3 hospitals. We investigated the incidence and clinical course of ARF in SAP patients. Then, we compared morbidity and mortality between the patients with ARF and normal renal function (NRF).RESULTS:Of the total 102 SAP patients, ARF was observed in 39 patients (38.2%). The peak serum creatinine level in ARF patients was 4.5+/-2.3 mg/dL. Eight of the 39 ARF patients (20.5%) received hemodialysis and ten patients (25.6%) died. When compared to NRF patiens, ARF patients (n=39) had higher incidence of dyspnea (17.9% vs 3.2%, p=0.011), loss of consciousness (17.9% vs 1.6%, p=0.003), and APACHE II scores more than 8 (92.3% vs 0%, p<0.001). The ARF group had also higher incidences of sepsis (35.9% vs 7.9%, p<0.001), multiorgan failure (15.4% vs 0%, p=0.001), respiratory failure (28.2% vs 4.7%, p=0.001) and mortality (25.6% vs 3.2%, p=0.001). Multivariate analysis demonstrated thrombocytopenia, hemoconcentration, and high LDH as independent risk factors of ARF in SAP patients.CONCLUSION:The incidence of ARF was high (38.2%) and ARF patients showed higher morbidity and mortality, compared to NRF patients. We suggest that early management of ARF should be performed for reducing the mortality in SAP patients. [공저자] Bioequivalence study of S-amlodipine Gentisate Conventional Versus new Formulation 작성자 김민걸 Year 2008 Journal J Korean Soc Clin Pharmacol Ther 추천 0 비추천 0 조회수 23 첨부파일 1 Background: Amlodipine, a dihydropyridine calcium channel blocker, is prescribed for the management of angina and hypertension. It is used therapeutically as a racemic mixture, composed of S- and R-enantiomers. However, its calcium channel blocking activity is confined to S-amlodipine; R-amlodipine has 1000-fold less activity than the S-enantiomer. Objective: The objective of this study was to compare the pharmacokinetic characteristics and safety profiles of the newly developed S-amlodipine formulation, composed of different additives, with those of the previously developed formulation. Methods: This randomized, double blind, two periods, two sequence crossover study was conducted in 24 healthy male volunteers at Seoul National University Hospital Clinical Trials Center. All subjects were randomly assigned to one of two sequence groups: (1) a single dose of the new S-amlodipine formulation (5 mg, 2.5mg/tablet) in the first study period, followed by a single dose of the reference S-amlodipine formulation (5 mg, 2.5mg/tablet) in the second study period, or (2) vice versa. A 14 day-washout separated the study periods. Blood samples for pharmacokinetic analysis of S-amlodipine were collected just before study drug administration and at predefined time points up to 168 hours post dose. Safety profiles including hematology, biochemistry, electrocardiography, and urinalysis were assessed throughout the study. Pharmacokinetics of the two formulations were characterized using noncompartmental model and compared between the formulations. Results: The pharmacokinetic profiles of S-amlodipine were comparable between the formulations. The mean [SD] values for Cmax in reference and test formulation (3.4 [0.8] ug/L vs 3.3 [0.88] ug/L, respectively) and AUC from time 0 to the last available measurement (AUC last) (159.2 [45.6] ug*h/L vs 160.6 [48.9] ug*h/L, respectively) were similar. The calculated 90% confidence interval of the corresponding ratios of log-transformed C max and AUC last, were 0.90~1.03 and 0.93~1.08, respectively. Neither formulation caused any serious adverse events. Conclustions: Both formulations were safe and well tolerated in tested dose, 5 mg of S-amlodipine. This study provides evidence for similar pharmacokinetic characteristics of the newly developed formulation of S-amlodipine to a previously prescribed formulation in healthy Korean male volunteers. [공저자] Comparative analysis of serum proteomes to discover biomarkers for ossification of the posterior longitudinal ligament 작성자 김민걸 Year 2007 Journal Spine 추천 0 비추천 0 조회수 22 첨부파일 1 Study design: Serum proteomes from normal subjects and the patients with ossification of the posterior longitudinal ligament (OPLL) were analyzed by using proteomics.Objectives: To identify novel serologic biomarkers for diagnosing OPLL.Summary of background data: OPLL can compress the spinal cord, and special planning is required for surgeries that are done from the front of the cervical spine. However, the definitive serologic biomarkers for OPLL are still unclear.Methods: The 2-dimensional electrophoresis patterns of sera from OPLL patients and normal subjects were compared. The differentially expressed spots were identified by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and electrospray ionization quadruple time-of-flight mass spectrometry.Results: Nine spots that were differentially expressed in the sera of OPLL patients were found and were identified. PRO2675, human serum albumin in a complex with myristic acid and tri-iodobenzoic acid, an unknown protein, chain B of the crystal structure of deoxy-human hemoglobin beta6, pro-apolipoprotein, ALB protein, retinol binding protein and chain A of human serum albumin mutant R218h complexed with thyroxine (3,3',5,5', tetraiodo-L-thyronine), were up-regulated in the sera of OPLL patients, whereas alpha1-microglobulin/bikunin precursor was down-regulated.Conclusions: These proteins could be used as diagnostic biomarkers of OPLL. [공저자] Effects of Static Magnetic Fields on Phagocytic Activity of Murine Peritoneal Macrophages 작성자 김민걸 Year 2006 Journal J Appl Pharm 추천 0 비추천 0 조회수 14 첨부파일 1 Electro-magnetic fields and static magnetic fields generated from diverse home/environmental sources have been reported that these could make harmful effects on the human health such as suppression of immunity and tumorigenesis. However, the mechanisms for the biologic effects of electro-magnetic fields or static magnetic fields are still remained unclear. In this study, we examined the in vitro effects of static magnetic fields (SMF) on murine peritoneal macrophages. The cells were exposed in vitro to SMF of 150sim250 or 350sim450 G in 5% CO2-incubator. The phagocytic activity of murine peritoneal macrophages was inhibited under exposure to SMF. In order to provide a more complete picture of molecular mechanism for the biological effect of SMF, we compared the levels of total proteins from macrophages with or without exposure to SMF using quantitative proteomic analysis. Proteins which were differentially expressed in macrophages exposed to SMF compared with non-exposed macrophages, were identified. Among them, the levels of trypsinogen 16, lactose-binding lectin Mac-2, galactoside-binding lectin, actin-like (Put. eta-actin, vimentin) and electron transferring flavoprotein beta polypeptide were enhanced under exposure to SMF. These results suggest that SMF can affect the phagocytic activity of macrophages via diverse mechanisms. [공저자] Postprandial glucose-lowering effects of fermented red ginseng in subjects with impaired fasting glucose or type 2 diabetes: A randomized, double-blin 작성자 김민걸 Year 2014 Journal BMC Complement Altern Med 추천 0 비추천 0 조회수 24 첨부파일 0 Background: Red ginseng is prepared by steaming raw ginseng, a process believed to increase the pharmacological efficacy. Further bioconversion of red ginseng through fermentation is known to increase its intestinal absorption and bioactivity, and bioconversion diminishes the toxicity of red ginseng's metabolite. This study was conducted to investigate the effects of daily supplementation with fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose or type 2 diabetes.Methods: This study was a four-week long, randomized, double-blind, placebo-controlled trial. Forty-two subjects with impaired fasting glucose or type 2 diabetes were randomly allocated to two groups assigned to consume either the placebo or fermented red ginseng (FRG) three times per day for four weeks. Fasting and postprandial glucose profiles during meal tolerance tests were assessed before and after the intervention.Results: FRG supplementation led to a significant reduction in postprandial glucose levels and led to an increase in postprandial insulin levels compared to the placebo group. There was a consistently significant improvement in the glucose area under the curve (AUC) in the FRG group. However, fasting glucose, insulin, and lipid profiles were not different from the placebo group.Conclusion: Daily supplementation with FRG lowered postprandial glucose levels in subjects with impaired fasting glucose or type 2 diabetes.Trial registration: ClinicalTrials.gov: NCT01826409. 처음 11 1 끝