drugset / Trial / NCT01306162
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects
Timeline
- Start
- 2011-02
- Primary completion
- 2011-05
- Completion
- —
Outcome
Missed primary endpoint
registry Geometric mean ratio TrtB: TrtA (%) 214 (90% CI 191 to 240) NCT01306162 ↗
registry Geometric mean ratio TrtD: TrtA (%) 225 (90% CI 156 to 326) NCT01306162 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 150 mg | Oral |
| Subject | Dronedarone | Small molecule | 400 mg | Oral |
Indications
No indication recorded.