[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover bioequivalence study of ezetimibe and rosuvastatin calcium tablets in healthy subjects under fasting and fed conditions
主要目的:以Sanofi-Aventis, S.R.O.持证的依折麦布瑞舒伐他汀钙片(规格:瑞舒伐他汀钙10 mg/依折麦布10 mg)为参比制剂,以海南葫芦娃药业集团股份有限公司持有的依折麦布瑞舒伐他汀钙片为受试制剂,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] Primary objective: Using ezetimibe and rosuvastatin calcium tablets (specifications: rosuvastatin calcium 10 mg/ezetimibe 10 mg) certified by Sanofi-Aventis, S.R.O. as the reference preparation and ezetimibe and rosuvastatin calcium tablets certified by Hainan Huluwa Pharmaceutical Group 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 fed conditions. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.