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 study of rosuvastatin calcium tablets in healthy subjects under fasting and fed conditions
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] Primary objective: To compare the absorption rate and extent of rosuvastatin calcium tablets produced by Jiangsu Yuexing Pharmaceutical Co., Ltd. (trade name: Crestor®, reference preparation) in healthy human bodies with those produced by IPR Pharmaceuticals, Inc., and to investigate the bioequivalence of the two preparations in humans.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.
100 Deals associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Jiangsu Yuexing Pharmaceutical Technology Co., Ltd.