Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects

• DOI: 10.12793/tcp.2020.28.e2
• Publication Date: 2020-03-31T07:55:28Z
• Authors: Xuanyou Jin; Eunwoo Kim; Ki Young Huh; Inyoung Hwang; Joo-Youn Cho; Kyung-Sang Yu; SeungHwan Lee
• Keywords: Pharmacodynamics; Crossover study; Bioequivalence; Fixed-dose combination

A fixed-dose combination (FDC) of gemigliptin/metformin can improve the medication adherence in patients with type 2 diabetes mellitus (T2DM). In this study, pharmacokinetic (PK) and pharmacodynamic (PD) profiles gemigliptin metformin were compared between FDC corresponding loose under fasted fed states. two-part, randomized, open label, single-dose, two-way crossover study was conducted healthy male subjects. Under (part 1) or 2) state, tablets sustained release (SR) 25/500 mg one tablet 50 two extended (XR) 500 orally administered each period a 7-day washout. Serial blood samples collected up to 48 hours determine drug concentration dipeptidyl peptidase 4 (DPP-4) activity. The concentration-time similar both Geometric mean ratios 90% confidence intervals for area curve maximum plasma within bioequivalence range (0.8-1.25) DPP-4 activity-time comparable that combination, showing inhibition-time inhibition regardless state. conclusion, PK/PD characteristics states.ClinicalTrials.gov Identifier: NCT03355014.