[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study of Iguratimod tablets developed by Nanjing Huanglong Biotechnology Co., Ltd. and Iguratimod tablets (trade name: Edexin®) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. in healthy Chinese subjects
以南京黄龙生物科技有限公司研制的艾拉莫德片(规格:25 mg)为受试制剂,持证商为海南先声药业有限公司的艾拉莫德片(商品名:艾得辛®,规格:25 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] The test preparation was Aguratimod tablets (specification: 25 mg) developed by Nanjing Huanglong Biotechnology Co., Ltd., and the reference preparation was Aguratimod tablets (trade name: Edexin®, specification: 25 mg) from Hainan Xiansheng Pharmaceutical Co., Ltd. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.