瑞舒伐他汀钙片在健康受试者中随机、开放、单次给药、两周期、两序列空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-cycle, two-sequence bioequivalence trial of rosuvastatin calcium tablets in healthy subjects in the fasting and postprandial states
主要目的:以江苏悦兴药业有限公司生产的瑞舒伐他汀钙片为受试制剂,与IPR Pharmaceuticals,Inc.生产的瑞舒伐他汀钙片(商品名:Crestor®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
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: To compare the rosuvastatin calcium tablets produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. with the rosuvastatin calcium tablets produced by IPR Pharmaceuticals, Inc. (trade name: Crestor®, reference preparation) The absorption rate and degree of absorption in healthy human body, and the human bioequivalence of the two preparations was investigated.
Secondary objective: To observe the safety of the test product and the reference product in healthy subjects.
100 Clinical Results associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.