[Translation] A single-center, randomized, open-label, two-formulation, single-dose, four-period, two-sequence, fully repeated crossover postprandial bioequivalence study of propafenone hydrochloride tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在餐后状态下口服受试制剂盐酸普罗帕酮片(规格:100mg,持证商:北京诚济制药股份有限公司)与参比制剂盐酸普罗帕酮片(规格:100mg,持证商:TOA EIYO LTD.(トーアエイヨー株式会社),商品名:Pronon)后在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:观察受试制剂盐酸普罗帕酮片和参比制剂盐酸普罗帕酮片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation propafenone hydrochloride tablets (specification: 100 mg, licensee: Beijing Chengji Pharmaceutical Co., Ltd.) and the reference preparation propafenone hydrochloride tablets (specification: 100 mg, licensee: TOA EIYO LTD., trade name: Pronon) in healthy subjects after oral administration in the fed state, and evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation propafenone hydrochloride tablets and the reference preparation propafenone hydrochloride tablets in healthy subjects.