drugset / Trial / NCT02710630
Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate. The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.
Timeline
- Start
- 2016-03-22
- Primary completion
- 2016-05-11
- Completion
- 2016-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dabigatran etexilate | Unknown | — | Oral |
Indications
No indication recorded.