Young healthy men (intended indication cardiovascular disease) MedDRA version: 17.1 Level: LLT Classification code 10071110 Term: Atherothrombosis prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Product Name: Clopidogrel
Product Code: SR25990C
Pharmaceutical Form: Solution for use in drinking water
INN or Proposed INN: CLOPIDOGREL
Current Sponsor code: SR25990C
Concentration unit: mg milligra
Sponsors
Sanofi-aventis
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male healthy subjects, between 18 and 40 years of age. 2. Weight between 60 kg and 90 kg, Body Mass Index between 18 and 28 kg/m2, inclusive (Appendix 1). 3. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). 4. Normal vital signs after 10 minutes in supine position: 95 mmHg =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease. 2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting. 3. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position. 4. Blood donation (including in the frame of a clinical trial) or general anesthesia within 3 months before administration. 5. Presence or history of any allergy or unusual reactions to drugs or anesthetics. 6. Unable to abstain from intensive muscular effort. 7. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development. 8. Subject in the exclusion period of a previous study. 9. Subject who cannot be contacted in case of emergency. 10. Any medication within one month before the administration, or within 6 times the elimination half-life of that drug. 11. Any drug intake within 3 months before administration which could lead to induction or inhibition of microsomal enzymes (Appendix 5). 12. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day) (Appendix 2). 13. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day). 14. Smoking more than 5 cigarettes or equivalent / day. 15. Positive HBs antigen or anti HCV antibody, or positive results for HIV tests. 16. Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety evaluation ;Timepoint(s) of evaluation of this end point: Study duration (D-1 - D24) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the bioavailabilty of clopidogrel administered as 75 mg Plavix® tablet to that of 75 mg of clopidogrel in drinkable solution, after single oral administration, in fasting state, to normal healthy subjects;Secondary Objective: Safety of treatment;Primary end point(s): Pharmacokinetic parameters ;Timepoint(s) of evaluation of this end point: t (0h-48h) | — |
Countries
France
Contacts
Public ContactTrial Transparency Team
Sanofi Aventis Recherche & Developpement
Outcome results
None listed