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Last refreshed on:. Main ID:. Date of registration:. Prospective Registration:. Primary sponsor:. Public title:. Bioequivalence test of clopidogrel hydrogen sulfate tablets fast. Scientific title:. Clofibrate Hydrochloride clopidogrel Tablets 75 mg random, open, four-cycle, fully repetitive crossover healthy adult subjects with after-prandial bioequivalence test.
Date of first enrolment:. Target sample size:. Recruitment status:. Study type:. Interventional study. Study design:. Randomized parallel controlled trial. I Phase I study. Countries of recruitment. Xiaoguang Huang. Broadwell Pharmaceutical LTD.
Guocheng Zhang. Inclusion criteria: 1. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2. Subjects including partners have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before the drug administration to the last 6 months after the last study drug administration.
See Appendix 5 for specific contraceptive measures; 4. Male and female subjects aged years including 18 and 50 years old ; 5. Male subjects weigh no less than 50 kg and female subjects weigh no less than 45 kg. Physical examination, normal or abnormal vital signs have no clinical significance. Exclusion criteria: 1. More than 5 cigarettes per day for 3 months before the trial; 2. Allergic history of test drugs, allergies multiple drugs and food allergies ; 3.
