[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover controlled bioequivalence study of iguratimod tablets in healthy subjects under fasting and fed conditions
研究空腹及餐后状态下单次口服受试制剂艾拉莫德片(规格:25mg,浙江高跖医药科技股份有限公司持证)与参比制剂艾拉莫德片(艾得辛®,规格:25mg,海南先声药业有限公司持证)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性
[Translation] To study the pharmacokinetics of the test preparation iguratimod tablets (specification: 25 mg, licensed by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) and the reference preparation iguratimod tablets (Edixin®, specification: 25 mg, licensed by Hainan Xiansheng Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state