[Translation] A single-dose, randomized, open-label, crossover, two-formulation, two-period postprandial bioequivalence study of iguratimod tablets in healthy subjects
主要目的:以金鸿药业股份有限公司的艾拉莫德片(规格:25mg)为受试制剂,以海南先声药业有限公司的艾拉莫德片(商品名:艾得辛®,规格:25mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Using the Iguratimod tablets (specification: 25 mg) of Jinhong Pharmaceutical Co., Ltd. as the test preparation and the Iguratimod tablets (trade name: Edexin®, specification: 25 mg) of Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation, according to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.