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Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

NCT ID: NCT01306162

Last Updated: 2014-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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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

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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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A: Dabigatran alone (Reference)

Capsule, oral administration with 240 mL water

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

150 mg as single dose

B: Dabigatran plus Dronedarone (Test)

Capsule and Tablets, oral administration with 240 mL water

Group Type EXPERIMENTAL

Dabigatran etexilate plus dronedarone

Intervention Type DRUG

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

C: Dabigatran plus Dronedarone (Test)

Capsule and Tablets, oral administration with 240 mL water

Group Type EXPERIMENTAL

Dabigatran etexilate plus dronedarone

Intervention Type DRUG

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

D: Dabigatran plus Dronedarone (Test)

Capsule and Tablets, oral administration with 240 mL water

Group Type EXPERIMENTAL

Dabigatran etexilate plus dronedarone

Intervention Type DRUG

dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid

E: Dabigatran plus Dronedarone (Test)

Capsule and Tablets, oral administration with 240 mL water

Group Type EXPERIMENTAL

Dabigatran etexilate plus dronedarone

Intervention Type DRUG

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

Interventions

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Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose

Intervention Type DRUG

Dabigatran etexilate

150 mg as single dose

Intervention Type DRUG

Dabigatran etexilate plus dronedarone

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

Intervention Type DRUG

Dabigatran etexilate plus dronedarone

dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid

Intervention Type DRUG

Dabigatran etexilate plus dronedarone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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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1160.112.1 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-024009-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1160.112

Identifier Type: -

Identifier Source: org_study_id

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