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Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

NCT01306162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-06-06

Study results available
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Summary

The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects

Conditions

  • Healthy

Interventions

DRUG

Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

DRUG

Dabigatran etexilate

150 mg as single dose

DRUG

Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)

DRUG

Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid

DRUG

Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-05-31

Countries

  • Germany

Study Locations

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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 NCT01306162 on ClinicalTrials.gov