[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of febuxostat tablets in Chinese healthy subjects in the postprandial state
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. Primary objective: To evaluate the bioequivalence of Febuxostat Tablets (Specification: 40 mg) produced by Guangdong Yililuo Pharmaceutical Co., Ltd. and the original Febuxostat Tablets (Specification: 40 mg, trade name: Uloric®, produced by Takeda Pharmaceuticals America, Inc.) in healthy adult subjects after a single oral administration in the fed state. 2. Secondary objective: To evaluate the safety of Febuxostat Tablets in healthy adult subjects.