drugset / Trial / NCT04070794

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

NCT04070794

Phase 1 Unknown 24 enrolled LG Chem
RandomizedCrossoverOpen-labelTreatment

Summary

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)

Timeline

Start
2019-11-01
Primary completion
2019-11-30
Completion
2019-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemigliptin Small molecule 50 mg Oral
Comparator Metformin Small molecule 1000 mg Oral