[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of Asartan Potassium Tablets in healthy participants under fasting and fed conditions
主要目的:以许昌恒生制药有限公司研制的美阿沙坦钾片为受试制剂,以Takeda Ireland Ltd.生产的美阿沙坦钾片(规格:80 mg,商品名:易达比®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价中国健康参与者单次空腹/餐后口服美阿沙坦钾片受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To use Asartan Potassium Tablets developed by Xuchang Hengsheng Pharmaceutical Co., Ltd. as the test preparation and Asartan Potassium Tablets (Specification: 80 mg, Trade Name: Edabi®) produced by Takeda Ireland Ltd. as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial state, and to evaluate whether the two preparations are bioequivalent.
Secondary objective: To evaluate the safety of the test preparation and reference preparation of Asartan Potassium Tablets after a single oral administration in fasting/postprandial state in healthy Chinese participants.