Myocardial infarction, cerebral infarction and other cardiovascular and cerebrovascular diseases
Conditions
Interventions
A:fasting adminstration of a branded formulation (reference) and then Clopidogrel Bisulfate 75mg-the generic formulation (test)
B:fasting adminstration of Clopidogrel Bisulfate 75mg-the generic formulation (test) and then a branded formulation (reference)
Sponsors
Phase I Clinical laboratory, Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 old (including 18 one full year of life), both men and women, single gender not less than one-third of the total; 2) Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg); Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 28 kg/m2; 3) According to past medical history, comprehensive physical examination and laboratory test, the researchers identified as healthy subjects; 4) Fertile woman should have negative pregnancy blood test ,and should take effective appropriate precautions from 14 days before the delivery to 6 months after the study; 5) Male should take effective appropriate precautions from 14 days before the delivery to 6 months after the study,and agree not to participate in sperm donation during the period; 6) Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent; 7) Subjects Can communicate well with the researchers and comply with the requirements of the entire study, and would like to check in phase I clinical research unit in accordance with the relevant provisions.
Exclusion criteria
Exclusion criteria: 1) Subject can't tolerate venipuncture; 2) Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator product; 3) Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc.; 4) Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination ) results judged as clinical significance of abnormal; 5) Hematology screening for HIV antibodies or HBV surface antigen or HCV antibody or TP antibody positive; 6) Women who are pregnant, pregnant, or plan to become pregnant in the near future; 7) The pregnancy test positive; 8) Male subjects did not take effective contraceptive measures or their spouse planned to conceive in the next six months; 9) Mental or legal disability; 10) History of prescription drug abuse and / or illicit drug abuse in the past 6 months; within 6 months prior to screening has a history of alcohol abuse, that drinking more than 14 units of alcohol a week (1 = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL liquor alcohol content of 40%, 5 oz or 150 mL wine); 11) within 6 months prior to screening smoking more than five cigarettes a day; 12) drug abuse or alcohol test positive; 13) Subjects have a history of hospitalization or surgery within 3 months before screening history (except appendicitis); 14) Participating in other clinical trials within the past 3 months; 15) Blood donation or a history of acute blood loss (more than 400 mL) or 1 months after the end of the test plan to blood donors; 16) use any other drugs within 2 weeks before the trial; 17) Subjects who drink strong tea, coffee and/or caffeinated drinks more than 1 l every day; 18) Subjects cannot understand the content of the informed consent and other do not accord with standard of trial; 19) Unsuitable to participate in the trial considered by the researchers (such as weak, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUCinf; | — |
Countries
China
Contacts
Public ContactXu Pingsheng
Xiangya Hospital, Central South University
Outcome results
None listed