[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of eperisone hydrochloride tablets in healthy Chinese subjects, with two preparations, two sequences, four periods, and complete repeated crossover
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂盐酸乙哌立松片(规格:50mg;生产企业:白云山东泰商丘药业有限公司)和参比制剂盐酸乙哌立松片(商品名:妙纳®;规格:50mg;持证商和生产企业:卫材(中国)药业有限公司)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂盐酸乙哌立松片和参比制剂盐酸乙哌立松片(妙纳®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Eperisone Hydrochloride Tablets (Specification: 50 mg; Manufacturer: Baiyunshan Dongtai Shangqiu Pharmaceutical Co., Ltd.) and the reference preparation Eperisone Hydrochloride Tablets (Trade name: Myona®; Specification: 50 mg; Licensee and Manufacturer: Eisai (China) Pharmaceutical Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation Eperisone Hydrochloride Tablets and the reference preparation Eperisone Hydrochloride Tablets (Myona®) in healthy Chinese subjects.