Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Warfarin; Drug: Warfarin 25 mg; Drug: BI 10773 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111331

2009-018088-29 (EudraCT Number)

1245.18

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Healthy male subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

BI 10773 25 mg

Experimental group

Description:

1 tablet 25 mg BI 10773 qd for 5 days

Treatment:

Drug: BI 10773 25 mg

Drug: BI 10773 25 mg

BI 10773 25 mg + Warfarin 25 mg

Experimental group

Description:

1 tablet 25 mg BI 10773 qd for 7 days plus 5 tablets 5 mg warfarin single dose

Treatment:

Drug: Warfarin 25 mg

Drug: BI 10773 25 mg

Drug: BI 10773 25 mg

Warfarin 25 mg

Active Comparator group

Description:

5 tablets 5 mg warfarin single dose

Treatment:

Drug: Warfarin