[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover bioequivalence study of ezetimibe and atorvastatin calcium tablets (I) in healthy subjects under fasting and fed conditions
主要研究目的:以Organon Healthcare GmbH持证的依折麦布阿托伐他汀钙片(I)(商品名:益立妥,规格:依折麦布10mg/阿托伐他汀钙10mg,以阿托伐他汀计)为参比制剂,以海南中旺医疗科技开发有限公司委托生产的依折麦布阿托伐他汀钙片(I)(规格:依折麦布10mg/阿托伐他汀钙10mg,以阿托伐他汀计)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉临床研究来评价两种制剂在空腹和餐后条件下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the ezetimibe atorvastatin calcium tablets (I) (trade name: Yilito, specification: ezetimibe 10mg/atorvastatin calcium 10mg, calculated as atorvastatin) certified by Organon Healthcare GmbH as the reference preparation, and the ezetimibe atorvastatin calcium tablets (I) (specification: ezetimibe 10mg/atorvastatin calcium 10mg, calculated as atorvastatin) commissioned by Hainan Zhongwang Medical Technology Development Co., Ltd. as the test preparation. A single-center, randomized, open, single-dose, two-preparation, two-sequence, four-period, completely repeated crossover clinical study was conducted to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.