[Translation] Bioequivalence study of febuxostat tablets in healthy Chinese participants: a single-dose, randomized, open-label, two-period, two-sequence, two-crossover, postprandial trial.
主要试验目的:以Teijin Pharma Limited持证的非布司他片(商品名:Feburic(菲布力)®)(规格:40mg)为参比制剂,以山西同达药业有限公司持有的非布司他片(规格:40mg)为受试制剂,通过单中心、随机、开放、单次给药、两周期、两序列、双交叉的临床试验来评价两种制剂在餐后状态下的人体生物等效性。
次要试验目的:观察受试制剂和参比制剂在中国健康试验参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of febuxostat tablets (trade name: Feburic®) (40 mg) licensed by Teijin Pharma Limited as the reference formulation and febuxostat tablets (40 mg) licensed by Shanxi Tongda Pharmaceutical Co., Ltd. as the test formulation in a single-center, randomized, open-label, single-dose, two-period, two-sequence, two-crossover clinical trial in postprandial status.
Secondary objective: To observe the safety of the test and reference formulations in healthy participants in China.