Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.

Detailed description:

Arms:
arm 1: 1 tablet 25 mg BI 10773 qd for 5 days arm 2: 1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose arm 3: 5 tablets 5 mg warfarin single dose

Interventions: intervention 1: BI 10773 25 mg intervention 2: Warfarin 25 mg intervention 3: BI 10773 25 mg intervention 4: Warfarin
Intervention descriptions: intervention 1: 25 mg BI 10773 qd for 5 days intervention 2: 25 mg Warfarin single dose intervention 3: 25 mg BI 10773 qd for 12 days intervention 4: 25 mg warfarin single dose with and without 50 mg BI 10773

Protocol document: