[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of iguratimod tablets in healthy adult Chinese subjects
主要研究目的:考察单次单剂量口服(空腹/餐后)受试制剂艾拉莫德片(规格:25mg,江苏永安制药有限公司生产)与参比制剂艾拉莫德片(商品名:艾得辛®,规格:25mg,海南先声药业有限公司持证生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为受试制剂艾拉莫德片的申报及临床用药提供参考依据。 次要研究目的:评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the relative bioavailability of the test preparation Iguratimod tablets (specification: 25 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Iguratimod tablets (trade name: Edesin®, specification: 25 mg, produced by Hainan Xiansheng Pharmaceutical Co., Ltd. with a license) in healthy Chinese subjects after a single oral dose (fasting/postprandial), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the test preparation Iguratimod tablets. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects after a single oral dose (fasting/postprandial).