/ Not yet recruitingNot Applicable 艾拉莫德片在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A single-dose bioequivalence clinical trial of iguratimod tablets in healthy Chinese subjects
主要目的:以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:25mg)为参比制剂,以山东新鲁医药科技有限公司研发的艾拉莫德片(规格:25mg)为受试制剂,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the reference preparation of Aguratimod tablets (trade name: Edexin, specification: 25 mg) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation and the test preparation of Aguratimod tablets (specification: 25 mg) developed by Shandong Xinlu Pharmaceutical Technology Co., Ltd. as the test preparation.
Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.
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