drugset / Trial / NCT04070794
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemigliptin | Small molecule | 50 mg | Oral |
| Comparator | Metformin | Small molecule | 1000 mg | Oral |