[Translation] A single-center, randomized, open-label, single (fasting/postprandial) oral administration, two-agent, two-sequence, four-cycle repeated crossover human bioequivalence prediction of topiramast tablets in healthy Chinese subjects. test
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托吡司特片(规格:60mg;生产企业:瑞阳制药股份有限公司)和参比制剂托吡司特片(商品名:Topiloric ;规格:60mg;持证商:株式会社富士薬品)后的药代动力学特征,初步评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂托吡司特片和参比制剂托吡司特片(Topiloric)在中国健康受试者中的安全性
[Translation] Main purpose: To observe the test preparation Topilast Tablets (specification: 60 mg; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation Topilast in Chinese healthy subjects in a fasting/postprandial state. The pharmacokinetic characteristics of the tablets (trade name: Topiloric; specification: 60 mg; licensee: Fuji Herbs Co., Ltd.), and the bioequivalence of the two preparations in the fasting/postprandial state was preliminarily evaluated.
Secondary objective: To observe the safety of the test preparation Topilast Tablets and the reference preparation Topiloric Tablets (Topiloric) in healthy Chinese subjects