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

NCT01111331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-07-23

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

BI 10773 25 mg

25 mg BI 10773 qd for 5 days

DRUG

Warfarin 25 mg

25 mg Warfarin single dose

DRUG

BI 10773 25 mg

25 mg BI 10773 qd for 12 days

DRUG

Warfarin

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111331 on ClinicalTrials.gov