[Translation] Topilast tablets (specification: 60 mg) developed by Zhejiang Brother Pharmaceutical Co., Ltd. and Topilast tablets (specification: 60 mg; trade name: TOPILORIC®) produced by Fujifilm Co., Ltd. were tested in Chinese healthy subjects. Single-center, randomized, open-label, two-formulation, fasting/prandial, single-dose, 2-sequence, 4-cycle, crossover design bioequivalence study
以浙江兄弟药业有限公司研制的托吡司特片(规格:60 mg)为受试制剂,以株式会社富士薬品上市的托吡司特片(规格:60 mg;商品名:TOPILORIC®)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Topilast tablets (specification: 60 mg) developed by Zhejiang Brothers Pharmaceutical Co., Ltd. were used as the test preparation, and Topilast tablets (specification: 60 mg; trade name: TOPILORIC®) marketed by Fujifilm Co., Ltd. were used as the test preparation. Reference preparations were used to examine the pharmacokinetic parameters and relative bioavailability of a single dose of the two preparations under fasting and postprandial conditions, and to evaluate whether the two preparations were bioequivalent. The safety and tolerability of both formulations in healthy humans were also evaluated.