Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: yes

Brief summary:
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration. To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation

Detailed description:

Arms:
arm 1: multiple dose of dabigatran arm 2: multiple dose of dabigatran arm 3: multiple dose of dabigatran

Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate
Intervention descriptions: intervention 1: Pellets (multiple dose of dabigatran) intervention 2: Granules resolved in reconstitution solution (multiple dose of dabigatran) intervention 3: Hard capsule (multiple dose of dabigatran)

Protocol document: