Type2 Diabetes Clinical Trial
Official title:
A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers
A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence,
crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers
with at least 7 days washout period between the administrations of investigational products
of two consecutive periods.
A: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food
(fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally
administered once with food (fed conditions)
[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.
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