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

PHASE1UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

November 30, 2019

Study Completion Date

December 30, 2019

Conditions
Type2 Diabetes
Interventions
DRUG

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)

Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.

DRUG

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)

Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LG Chem

INDUSTRY

NCT04070794 - Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions | Biotech Hunter | Biotech Hunter