[Translation] A single-dose, randomized, open-label, completely repeated crossover, two-dose, four-period fasting human bioequivalence study of eperisone hydrochloride tablets in healthy subjects
主要目的:以上海博悦生物科技有限公司的盐酸乙哌立松片(规格:50mg;生产厂家:华益泰康药业股份有限公司)为受试制剂,以卫材(中国)药业有限公司的盐酸乙哌立松片(商品名:妙纳®,规格:50mg;生产厂家:卫材(中国)药业有限公司)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Using Eperisone Hydrochloride Tablets (Specification: 50 mg; Manufacturer: Huayi Taikang Pharmaceutical Co., Ltd.) of Shanghai Boyue Biotechnology Co., Ltd. as the test preparation and Eperisone Hydrochloride Tablets (Trade name: Myona®, Specification: 50 mg; Manufacturer: Eisai (China) Pharmaceutical Co., Ltd.) of Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, according to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.