[Translation] A single-center, randomized, open-label, single-dose, fasting oral bioequivalence study of febuxostat tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, double-crossover
"主要目的:观察中国健康受试者在空腹状态下单次口服受试制剂非布司他片(规格:40mg;生产企业:涿州东乐制药有限公司)和参比制剂非布司他片[商品名:Feburic(菲布力)®;规格:40mg;生产厂家:TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY]后的药代动力学特征,评价空腹状态下两种制剂的生物等效性。
次要目的:观察受试制剂非布司他片和参比制剂非布司他片Feburic(菲布力)®在中国健康受试者中的安全性。"
[Translation] "Primary objective: To observe the pharmacokinetic characteristics of the test preparation Febuxostat tablets (Specification: 40 mg; Manufacturer: Zhuozhou Dongle Pharmaceutical Co., Ltd.) and the reference preparation Febuxostat tablets [Trade name: Feburic®; Specification: 40 mg; Manufacturer: TEIJIN PHARMA LIMITED IWAKUNI PHARMACEUTICAL FACTORY] after a single oral administration in the fasting state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting state.
Secondary objective: To observe the safety of the test preparation Febuxostat tablets and the reference preparation Febuxostat tablets Feburic® in healthy Chinese subjects."