Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects

BACKGROUND: In type 2 diabetes mellitus therapy, fixed-dose combination (FDC) can offer not only benefits in glucose control via the combined use of agents, but also increase patient compliance. The aim of this study was to assess the pharmacokinetic equivalence of the high dose of the FDC tablet (gemigliptin/metformin sustained release [SR] 50/1,000 mg) and a corresponding co-administered dose of individual tablets. METHODS: This study was randomized, open-label, single dose, two treatments, two-period, crossover study, which included 24 healthy subjects. Subjects received the FDC or individual tablets of gemigliptin (50 mg) and metformin XR (1,000 mg) in each period. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of the FDC tablet and co-administration of individual tablet for both gemigliptin and metformin were calculated. RESULTS: The GMRs (FDC tablets/co-administration; 90% CIs) for Cmax and AUClast of gemigliptin were 1.079 (0.986–1.180) and 1.047 (1.014–1.080), respectively. For metformin, the GMRs for Cmax, and AUClast were 1.038 (0.995–1.083) and 1.041 (0.997–1.088), respectively. The 90% CIs for GMRs of Cmax and AUClast for gemigliptin and metformin fell entirely within bounds of 0.800–1.250. Both administration of FDC tablet and co-administration of individual tablets were well tolerated. CONCLUSION: FDC tablet exhibited pharmacokinetic equivalence and comparable safety and tolerability to co-administration of corresponding doses of gemigliptin and metformin XR as individual tablets. Trial registry at ClinicalTrials.gov, NCT02056600.

Influencing Factors on Cardio-cerebrovascular Disease Risk Factors in Young Men: Focusing on Obesity Indices

PURPOSE: The purpose of this study was to investigate influences of drinking, smoking, and obesity indices on cardio-cerebrovascular disease risk factors in Korean young men. METHODS: The subjects were 234 young men, aged 20 to 39 years. Body mass index (BMI), percent body fat (PBF), body fat mass (kg), and waist hip ratio (WHR) were measured as obesity indices. Systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood sugar (FBS), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were measured as cardio-cerebrovascular disease risk factors. The data were analyzed by t-test, ANOVA, Pearson's correlation coefficient, and multiple regression analysis using SAS 9.4. RESULTS: Statistically significant factors were BMI for SEP; age, degree of drinking, body fat mass for DBP; WHR for TC; WHR and age for TG; age, degree of smoking and PBF for HDL-C; WHR, age and degree of smoking for LDL-C. CONCLUSION: Factors identified in this study need to be considered in cardio-cerebrovascular disease prevention programs for young men.