[Translation] A single-center, open-label, randomized, single-dose, two-sequence, two-period fasting and two-feeding, double-crossover bioequivalence study of roxadustat capsules in healthy subjects.
主要研究目的:评价青岛国信制药有限公司生产的罗沙司他胶囊(规格:50 mg/粒)与珐博进(中国)医药技术开发有限公司持证的罗沙司他胶囊(商品名:爱瑞卓®,规格:50 mg/粒)空腹及餐后单次口服给药在中国健康人群中的生物等效性。
次要研究目的:评价受试制剂和参比制剂在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to evaluate the bioequivalence of rosuvastatin capsules (specification: 50 mg/capsule) produced by Qingdao Guoxin Pharmaceutical Co., Ltd. and rosuvastatin capsules (trade name: Aeridro®, specification: 50 mg/capsule) certified by FibroGen (China) Pharmaceutical Technology Development Co., Ltd., in Chinese healthy people after single oral administration on an empty stomach or after meals.
Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects.