drugset / Trial / NCT02710630

Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

NCT02710630

Phase 1 Completed 35 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Comparator Dabigatran etexilate Unknown Oral

Indications

No indication recorded.