drugset / Trial / NCT05083949
A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
RandomizedCrossoverOpen-labelTreatment
Summary
This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).
Timeline
- Start
- 2021-07-23
- Primary completion
- 2021-08-06
- Completion
- 2021-09-09
Outcome
Met primary endpoint
registry Ratio of GLSM (%) 101.36 (90% CI 96.39 to 106.59) NCT05083949 ↗
registry Ratio of GLSM (%) 98.11 (90% CI 94.24 to 102.15) NCT05083949 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 12.5 mg | Oral |
| Subject | Metformin | Small molecule | 850 mg | Oral |
Indications
No indication recorded.