双嘧达莫片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence test of dipyridamole tablets in fasting/fed state of healthy subjects
主要目的:以黑龙江亿达鸿药业有限公司生产的双嘧达莫片(规格:25mg)为受试制剂,按生物等效性试验的有关规定,以Nippon Boehringer Ingelheim Co., Ltd.持证的双嘧达莫片(商品名:Persantin,规格:25mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Taking dipyridamole tablets (specification: 25mg) produced by Heilongjiang Yidahong Pharmaceutical Co., Ltd. Dipyridamole Tablets (trade name: Persantin, specification: 25mg) was used as the reference preparation, and the human bioequivalence test was carried out in the fasting/fed state to evaluate the effect of the test preparation and the reference preparation in healthy subjects. Bioequivalence.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
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