Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation and the treatment of venous thromboembolism. It is administered with fixed dose and does not require laboratory monitoring because of the low inter and intra individual pharmacokinetic (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic polymorphism. The inhibition of this protein can cause a significant increase in intestinal absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major drug interactions have been identified : quinidine (cons-indication) and amiodarone (precautions). It is likely that other interactions exist and can be clinically significant in patients not selected such as testing. The development of tools to study the influence of P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic polymorphism, the study of the latter is an important element in the detection of drug interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to evaluate the primary mechanism of drug interaction of dabigatran and optimize the experimental design of studies to be conducted.

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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

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm A

Dabigatran then dabigatran and clarithromycin

Group Type ACTIVE_COMPARATOR

Dabigatran then dabigatran and clarithromycin

Intervention Type DRUG

D4 : dabigatran 300 mg (4 tablets) one time. D8 to D10 : Clarithromycin 500mg (1 tablet) twice daily. D11 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets)

Arm B

Clarithromycin and dabigatran and dabigatran

Group Type ACTIVE_COMPARATOR

Clarithromycin and dabigatran then dabigatran

Intervention Type DRUG

D1 to D3 : Clarithromycin 500mg (1 tablet) twice daily. D4 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets). D11 : dabigatran 300 mg (4 tablets) one time.

Interventions

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Dabigatran then dabigatran and clarithromycin

D4 : dabigatran 300 mg (4 tablets) one time. D8 to D10 : Clarithromycin 500mg (1 tablet) twice daily. D11 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets)

Intervention Type DRUG

Clarithromycin and dabigatran then dabigatran

D1 to D3 : Clarithromycin 500mg (1 tablet) twice daily. D4 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets). D11 : dabigatran 300 mg (4 tablets) one time.

Intervention Type DRUG

Other Intervention Names

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Dabigatran (Pradaxa)75 mg Clarithromycin (Zeclar) 500 mg Dabigatran (Pradaxa) 75 mg Clarithromycin (Zeclar) 500 mg

Eligibility Criteria

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Inclusion Criteria

* affiliated or beneficiary of a social security category
* having signed the inform consent form
* having signed the genetic consent form
* weight between 60 and 85 kg
* normal clinical exam
* normal biological exam

Exclusion Criteria

* contra-indication to dabigatran
* contra-indication to clarithromycin
* previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease
* smoker
* peptic ulcer
* severe liver disease
* severe kidney failure
* previous surgery within one month

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes