[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, two-sequence, double-crossover bioequivalence study of Febuxostat tablets in healthy subjects in the postprandial state
主要目的: 以河北爱普制药有限公司持证的非布司他片(规格:40mg)为受试制剂T ,以Teijin Pharma Limited生产的非布司他片(规格:40mg,商品名:Feburic® )为参比制剂R,比较受试制剂与参比制剂的药代动力学参数,评价两制剂在餐 后状态下的人体生物等效性。 次要目的:观察受试制剂非布司他片T和参比制剂非布司他片R(商品名: Feburic®)在健康受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic parameters of the test preparation and the reference preparation, using the febuxostat tablets (specification: 40 mg) licensed by Hebei Aipu Pharmaceutical Co., Ltd. as the test preparation T and the febuxostat tablets (specification: 40 mg, trade name: Feburic®) produced by Teijin Pharma Limited as the reference preparation R, and to evaluate the bioequivalence of the two preparations in the human body under the fed state. Secondary objective: To observe the safety of the test preparation, febuxostat tablets T, and the reference preparation, febuxostat tablets R (trade name: Feburic®) in healthy subjects.