[Translation] A single-dose, randomized, open-label, two-cycle, double-crossover, fasting and postprandial bioequivalence study of Febuxostat tablets in Chinese healthy subjects
主要研究目的:以TEIJIN PHARMA LIMITED持证的非布司他片(规格:20 mg ,商品名:菲布力®)为参比制剂,以辽宁新高制药有限公司生产的非布司他片(规格:20 mg)为受试制剂,通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research purpose: Use TEIJIN PHARMA LIMITED’s licensed febuxostat tablets (specification: 20 mg, trade name: Febuxostat®) as the reference preparation, and use febuxostat tablets produced by Liaoning Xingao Pharmaceutical Co., Ltd. (specification: : 20 mg) is the test preparation. The human bioequivalence of the two preparations in the fasting and postprandial states was evaluated through a single-center, single-dose, randomized, open-label, two-cycle, double-crossover design clinical study.
Secondary research purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.