[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of measartan potassium tablets in healthy subjects, administered orally once or twice daily, in both fasting and postprandial doses.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂美阿沙坦钾片(规格:80mg,苏州弘森药业股份有限公司生产,苏州弘森药业股份有限公司持证)与参比制剂美阿沙坦钾片(易达比®(Edarbi®),规格:80mg,Takeda Ireland Ltd.生产, Takeda Pharma A/S持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:空腹和餐后状态下,研究单次口服受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片(易达比®(Edarbi®))在健康成年受试者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation measartan potassium tablets (80 mg, manufactured by Suzhou Hongsen Pharmaceutical Co., Ltd., certified by Suzhou Hongsen Pharmaceutical Co., Ltd.) and the reference formulation measartan potassium tablets (Edarbi®, 80 mg, manufactured by Takeda Ireland Ltd., certified by Takeda Pharma A/S) in healthy adult subjects under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To investigate the safety of a single oral dose of the test formulation measartan potassium tablets and the reference formulation measartan potassium tablets (Edarbi®) in healthy adult subjects under fasting and postprandial conditions.