Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine

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

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor, low or non-responder to this therapeutic. However, drug-drug interactions may lead to decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the antiplatelet effect of clopidogrel.

The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic and pharmacodynamic of clopidogrel.

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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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1

Clopidogrel then fluoxetine+clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel then fluoxetine+clopidogrel

Intervention Type DRUG

D1 : clopidogrel (Plavix) 600mg (8 tablets) one time D45 to D48 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D49 : 20mg Fluoxetine + 600mg Clopidogrel

2

Fluoxetine+clopidogrel then clopidogrel

Group Type ACTIVE_COMPARATOR

Fluoxetine+clopidogrel then clopidogrel

Intervention Type DRUG

D1 to D4 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D5: 20mg Fluoxetine + Clopidogrel (Plavix) 600mg (8 tablets) one time D49 : Clopidogrel 600mg one time

Interventions

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Clopidogrel then fluoxetine+clopidogrel

D1 : clopidogrel (Plavix) 600mg (8 tablets) one time D45 to D48 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D49 : 20mg Fluoxetine + 600mg Clopidogrel

Intervention Type DRUG

Fluoxetine+clopidogrel then clopidogrel

D1 to D4 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D5: 20mg Fluoxetine + Clopidogrel (Plavix) 600mg (8 tablets) one time D49 : Clopidogrel 600mg one time

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed an informed consent
* Body mass: 60 to 85 Kg
* Platelet count: 180 to 350 G/L
* % platelet aggregation \> 70%
* Subjects are to be in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results including liver function, renal and full blood count

Exclusion Criteria

* Subject with an history of seizure disorder
* Subject with a known allergy fluoxetine or clopidogrel
* Cigarette smoking
* Subject with a history of hemorrhagic disease
* Peptic ulcer
* Psychiatric disorders
* Participation in another clinical or device trial within the three previous months
* Subject who is currently taking medications
* Subject who is currently taking medications for depression
* Subject with an history of depression (MADRS score \< 15)
* Hepatic insufficiency

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes