Status:
COMPLETED
Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
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-re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00732290
Start Date
February 1 2009
End Date
May 1 2009
Last Update
March 25 2013
Active Locations (1)
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1
Service de Medecin et Therapeutique, Unite de Recherche Clinique Groupe de Recherche sur la Thrombose (EA3065)
Saint-Etienne, France, 42055