drugset / Trial / NCT06248801
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
RandomizedCrossoverOpen-labelBasic science
Summary
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 14 days washout period between the doses.
Timeline
- Start
- 2024-09-05
- Primary completion
- 2024-10-01
- Completion
- 2024-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1000 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |
Indications
No indication recorded.