Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 180
Healthy volunteers: yes

Brief summary:
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.

The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.

Detailed description:

Arms:
arm 1: Capsugel (T), oral administration arm 2: Qualicaps (R), oral administration

Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: 150 mg Capsugel (T) intervention 2: 150 mg Qualicaps (R)

Protocol document: