[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover design trial of rosuvastatin capsules
主要目的:
以四川国为制药有限公司生产的罗沙司他胶囊(50mg/粒)为受试制剂,以珐博进(中国)医药技术开发有限公司生产的罗沙司他胶囊(50mg/粒)为参比制剂,考察两制剂的生物等效性。
次要目的:
考察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose:
Using rosuvastatin capsules (50 mg/capsule) produced by Sichuan Guowei Pharmaceutical Co., Ltd. as the test preparation and rosuvastatin capsules (50 mg/capsule) produced by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. as the reference preparation, the bioequivalence of the two preparations was investigated.
Secondary purpose:
Investigate the safety of the test preparation and the reference preparation in healthy subjects.