[Translation] Single-center, randomized, open-label, single-dose, two-cycle, double-crossover postprandial bioequivalence study of olmesartan medoxomil tablets in healthy subjects
主要目的:以上海信谊百路达药业有限公司生产的奥美沙坦酯片与第一三共制药(上海)有限公司生产的奥美沙坦酯片,按生物等效性试验的相关规定,比较在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:评价中国健康受试者单次餐后口服受试制剂和参比制剂后的安全性。
[Translation] Main purpose: To compare olmesartan medoxomil tablets produced by Shanghai Xinyi Bailuda Pharmaceutical Co., Ltd. and olmesartan medoxomil tablets produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd. according to the relevant regulations of bioequivalence test Pharmacokinetic behavior in healthy Chinese subjects, evaluating the bioequivalence of the two formulations.
Secondary objective: To evaluate the safety of the test preparation and reference preparation after a single meal in healthy Chinese subjects.