[Translation] Bioequivalence trial of febuxostat tablets in Chinese healthy subjects in a single-center, randomized, open-label, two-period, two-crossover design
1.主要目的:评价广东一力罗定制药有限公司生产的非布司他片(规格:40mg)与原研药非布司他片(规格:40mg,商品名:Uloric®,Takeda Pharmaceuticals America, Inc.生产)在健康成年受试者餐后状态下单次口服给药的人体生物等效性。 2.次要目的:评价非布司他片在健康成年受试者中的安全性。
[Translation] 1. Main purpose: to evaluate the febuxostat tablets (specification: 40mg) produced by Guangdong Yililuo Custom Pharmaceutical Co., Ltd. and the original research drug febuxostat tablets (specification: 40mg, trade name: Uloric®, Takeda Pharmaceuticals America, Inc. . production) human bioequivalence of a single oral dose in healthy adult subjects in the fed state. 2. Secondary objective: To evaluate the safety of febuxostat tablets in healthy adult subjects.