[Translation] Bioequivalence study of methylphenidate hydrochloride extended-release tablets in healthy subjects in randomized, open-label, single-dose, four-period, fully repeated crossover fasting and fed states
主要目的:以合肥立方制药股份有限公司提供的盐酸哌甲酯缓释片为受试制剂,以Janssen-Cilag Manufacturing, LLC生产的盐酸哌甲酯缓释片(商品名:专注达®,持证商:Janssen Pharmaceuticals Inc)为参比制剂,按生物等效性试验的相关规定,比较空腹和餐后状态下单次口服盐酸哌甲酯缓释片在中国健康受试者体内的药代动力学,评价两种制剂的生物等效性。
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: Take methylphenidate hydrochloride sustained-release tablets provided by Hefei Lifang Pharmaceutical Co., Ltd. as the test preparation, and use methylphenidate hydrochloride sustained-release tablets produced by Janssen-Cilag Manufacturing, LLC (trade name: Focused Trader: Janssen Pharmaceuticals Inc) as the reference preparation, according to the relevant provisions of the bioequivalence test, to compare the pharmacokinetics of a single oral administration of methylphenidate hydrochloride sustained-release tablets in Chinese healthy subjects under fasting and postprandial states , to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.