[Translation] A single-center, randomized, open-label, two-dose, fasting/postprandial, single-dose, 2-sequence, 4-period, crossover-design bioequivalence study of 60 mg topirastat tablets developed by Zhejiang Brothers Pharmaceutical Co., Ltd. and 60 mg topirastat tablets developed by Fuji Pharmaceutical Co., Ltd. in healthy Chinese subjects
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] The 60 mg topirastat tablets developed by Zhejiang Brothers Pharmaceutical Co., Ltd. were used as the test preparation, and the 60 mg topirastat tablets marketed by Fuji Pharmaceutical Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.