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

NCT ID: NCT01111331

Last Updated: 2014-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 10773 25 mg

1 tablet 25 mg BI 10773 qd for 5 days

Group Type EXPERIMENTAL

BI 10773 25 mg

Intervention Type DRUG

25 mg BI 10773 qd for 12 days

BI 10773 25 mg + Warfarin 25 mg

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

Group Type EXPERIMENTAL

BI 10773 25 mg

Intervention Type DRUG

25 mg BI 10773 qd for 5 days

Warfarin 25 mg

Intervention Type DRUG

25 mg Warfarin single dose

Warfarin 25 mg

5 tablets 5 mg warfarin single dose

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

25 mg warfarin single dose with and without 50 mg BI 10773

Interventions

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BI 10773 25 mg

25 mg BI 10773 qd for 5 days

Intervention Type DRUG

Warfarin 25 mg

25 mg Warfarin single dose

Intervention Type DRUG

BI 10773 25 mg

25 mg BI 10773 qd for 12 days

Intervention Type DRUG

Warfarin

25 mg warfarin single dose with and without 50 mg BI 10773

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy male subjects
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.18.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-018088-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.18

Identifier Type: -

Identifier Source: org_study_id

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