[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence pilot study of topiramate tablets in healthy Chinese subjects with two formulations, two sequences, and four-period 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] Primary objective: To observe the pharmacokinetic characteristics of the test preparation Topiramate Tablets (Specification: 60 mg; Manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation Topiramate Tablets (Trade name: Topiloric; Specification: 60 mg; Licensee: Fuji Pharmaceutical Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation Topiramate Tablets and the reference preparation Topiramate Tablets (Topiloric) in healthy Chinese subjects