Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers
Summary
The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.
Timeline
- Start
- 2010-05
- Primary completion
- 2010-07
- Completion
- —
Outcome
Met primary endpoint
registry Geometric Mean ratio 100.89 (90% CI 96.86 to 105.10); ANOVA NCT01111331 ↗
registry Geometric Mean Ratio 100.64 (90% CI 89.79 to 112.80); ANOVA; note: p-value for geometric mean ratio being outside interval 80% to 125% NCT01111331 ↗
registry Geometric Mean Ratio 98.49 (90% CI 95.29 to 101.80); ANOVA NCT01111331 ↗
registry Geometric Mean Ratio 97.89 (90% CI 91.12 to 105.15); ANOVA NCT01111331 ↗
registry Geometric Mean Ratio 95.88 (90% CI 93.40 to 98.43); ANOVA NCT01111331 ↗
registry Geometric Mean Ratio 98.88 (90% CI 91.84 to 106.47); ANOVA; note: p-value for geometric mean ratio being outside interval 80% to 125% NCT01111331 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |
| Subject | Warfarin | Small molecule | 25 mg | Oral |
Indications
No indication recorded.