[Translation] A single-dose, randomized, open-label, two-period, double-crossover, fasting bioequivalence study of febuxostat tablets in healthy Chinese 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] The main purpose of the study is to use the febuxostat tablets (specification: 20 mg, trade name: Feibuli®) licensed by TEIJIN PHARMA LIMITED as the reference preparation and the febuxostat tablets (specification: 20 mg) produced by Liaoning Xingao Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.