[Translation] To evaluate the effect of the test preparation leflunomide tablets and the reference preparation Arava® (leflunomide tablets) in healthy adult male subjects in a single-center, open-label, randomized, single-dose, single-cycle state in a fasting/postprandial state , parallel design bioequivalence studies.
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] A single oral dose of test preparation leflunomide tablets (specification: 20mg/tablet, produced by Merro Pharmaceutical Co., Ltd.) and reference preparation leflunomide tablets (Arava®, specification: 20mg) in fasting/postprandial state were studied. /tablet; manufactured by SANOFI AVENTIS U.S. LLC) pharmacokinetics in healthy adult male subjects, evaluating the bioequivalence of the two formulations orally in the fasting/fed state, and safety in healthy adult male subjects sex.