acute coronary syndrome
Conditions
Interventions
Sponsors
Jilin University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent form, and well understand the details, process, and the possible adverse reaction of the clinic trial; 2. Be able to complete the study in accordance with the clinical trial scheme; 3. The subjects (including male) there will be no pregnancy in the next six months and voluntary to take effective contraceptive measures; 4. Aged 18-65 year-old male and female (including 18 and 65 years old); 5. Male subjects not less than 50 kg, and female not less than 45 kg , BMI within 18 ~ 28 (including threshold); 6. Good health, Physical examination is normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Daily smoking reach more than 5 pieces within 3 months before the study; 2. There is allergy history for drug (vicagrel or clopidogrel) or its accessories; 3. There is a history of drug and/or alcohol abuse; 4. There is a history of blood donation or massive blood loss (> 450 ml) within 3 months before the study; 5. Taken any drugs that can change liver enzyme activity within 28 days before the study; 6. Taken any drugs including prescription drugs, over-the-counter medications, vitamins or herbal products Within 14 days before the study; 7. Taken any special diet (including the dragon fruit, mango, pomelo, and/or yellow purine diet) or strenuous exercise, or other factor affecting absorption, distribution, metabolism and excretion within 2 weeks before the study; 8. Taken the inhibitors or inducers for CYP3A4, P-gp or Bcrp, such as itraconazoleKetoconazoledronedarone and so on; 9. There will be major change in diet or exercise habits; 10. Taken study drugs or participated in other clinical trials within 3 months before the study; 11. There is a history of dysphagia or gastrointestinal diseases affecting drug absorption; 12. The subject has disease increasing the risk of hemorrhage, such as haemorrhoids, acute gastritis, gastric and duodenal ulcer, thrombocytopenic purpura, hemophilia and so on; 13. Electrocardiogram is abnormal and has clinical significance; 14. Female subject is in lactation or positive serum pregnancy outcomes; 15. Clinical laboratory examination were abnormal and had clinical significance; 16. Merging other virus infection; 17. Suffering from acute disease during screening stage or before taking study drug; 18. Taking in chocolateany food or drink containing caffeine or xanthine within 48 hours before study drug 19. Taking in any alcoholic products within 24 hours before study drug; 20. Screening for drug and alcohol is positive, had a history of substance abuse in the past five years or used narcotics within 3 months before the study; 21. Researchers think existing other factors not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of AE;inhibition of platelet aggregation;Pharmacokinetic indicators; | — |
Countries
China
Contacts
Public ContactYongqiang Liu
Jiangsu vcare pharmaceutical technology co., LTD
Outcome results
None listed