Pharmacokinetics and bioequivalence
Conditions
Interventions
1:Phase I:clopidogrel bisulfate tablets produced by Hunan Dinuo Pharmaceutical Co. Ltd. Phase II:clopidogrel bisulfate tablets produced by Sanofi - Aventis Pharmaceutical Co. Ltd. of Hangzhou .
Sponsors
Phase I Clinical laboratory, Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male; 2. Aged 18~45 years, with the age difference less than 10 years; 3. Body weight: Body Mass Index (BMI)=weight (kg)/height m^2; BMI in this test was within 19~26; 4. All subjects are voluntary to take part in the trial and signed the informed consent form; 5. Subjects can communicate well and complete the study.
Exclusion criteria
Exclusion criteria: 1. serious disease or receive major surgery 4-week within study; 2. allergy to the study drug; 3. Diseases of the cardiovascular system patients (hypertension, hyperlipidemia,arrhythmia, cardiac insufficiency, and et al.); 4. history of severe disease or endocrine system, nervous system disease,lung,blood, immunology, psychiatric disease and metabolic disorder; 5. history of some diseases that can influence drug absorption and metabolic; 6. laboratory tests (blood routine, urine routine, liver and kidney function, blood glucose, blood lipid, abnormal ion) has a clincal significance; 7. electrocardiogram and physical examination have a clinical significance; 8. HIV and RPR test were positive; 9. hepatitis B surface antigen and hepatitis C antibody were positive; 10. alcoholics 6 months before study; 11. soft drug users (ecstasy,KEN, Magu,et al) within 3 months or hard drugs users (cocaine, diamorphine, et al) within 1 year; 12. use of drug-metabolizing- enzyme-modifying drugs within 30 days of admission; 13. any drug users 14 day before study; 14. Blood donator 3 months before study; 15. Daily smoking more than 3 minths before study; 16. have special requirements on food; 17. tea or coffee abusers; 18. other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma of concentration of clopidogrel and clopidogrel acid; | — |
Countries
China
Contacts
Public ContactXu Pingsheng
Xiangya Hospital, Central South University
Outcome results
None listed