[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of rosuvastatin capsules developed by Qingdao Guofeng Pharmaceutical Co., Ltd. of Shanghai Pharmaceutical Group and the original reference preparation in healthy Chinese subjects
以上海医药集团青岛国风药业股份有限公司研制的罗沙司他胶囊(规格:50 mg)为受试制剂,持证商为珐博进(中国)医药技术开发有限公司的罗沙司他胶囊(商品名:爱瑞卓®,规格:50 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Rosuvastatin capsules (specification: 50 mg) developed by Qingdao Guofeng Pharmaceutical Co., Ltd. of Shanghai Pharmaceutical Group were used as the test preparation, and Rosuvastatin capsules (trade name: Aeridro®, specification: 50 mg) of FibroGen (China) Pharmaceutical Technology Development Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.