Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
[Objectives] Primary: To investigate the food‐effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions [Admission and Confinement] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in‐house stay until 24 hours post‐dose. Fasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in‐house stay until 24 hours post‐dose.
Epistemonikos ID: d2c096883da343ad7c828685272cc94f05d740c5
First added on: May 22, 2024