drugset / Trial / NCT06233201
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator
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 fed condition and at least 7 days washout period between the doses.
Timeline
- Start
- 2024-06-04
- Primary completion
- 2024-07-14
- Completion
- 2024-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Sitagliptin | Small molecule | 50 mg | Oral |
Indications
No indication recorded.