drugset / Trial / NCT03629054
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal. The assessment of safety and tolerability will be the secondary objective of this trial.
Timeline
- Start
- 2018-08-27
- Primary completion
- 2018-11-05
- Completion
- 2018-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | — | Oral |
| Subject | Linagliptin | Small molecule | — | Oral |
| Subject | Metformin | Small molecule | — | Oral |
Indications
No indication recorded.