[Translation] A single-center, open-label, randomized, single-dose, single-period, parallel-design bioequivalence study was conducted to evaluate the bioequivalence of the test preparation, leflunomide tablets, and the reference preparation, Arava® (leflunomide tablets), in healthy adult male subjects under fasting/fed conditions.
研究空腹/餐后状态下单次口服受试制剂来氟米特片(规格:20mg/片,美罗药业股份有限公司生产)与参比制剂来氟米特片(Arava®,规格:20mg/ 片 ;SANOFI AVENTIS U.S.LLC 生产)在健康成年男性受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性,以及在健康成年男性受试者中的安全性。
[Translation] The pharmacokinetics of the test preparation leflunomide tablets (specification: 20 mg/tablet, produced by Merro Pharmaceutical Co., Ltd.) and the reference preparation leflunomide tablets (Arava®, specification: 20 mg/tablet; produced by SANOFI AVENTIS U.S. LLC) in healthy adult male subjects were studied after a single oral administration in the fasting/fed state, and the bioequivalence of the two preparations in the fasting/fed state and their safety in healthy adult male subjects were evaluated.