Chifeng Wanze Intelligent Medicine Co., Ltd.

To evaluate the bioequivalence of a single fasting and a single postprandial oral administration of 25 mg of Iguratimod tablets (specification: 25 mg/tablet; test preparation) produced by Chifeng Wanze Pharmaceutical Co., Ltd. and 25 mg of Iguratimod tablets (Edixin, specification: 25 mg/tablet; reference preparation) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. in healthy Chinese participants; Secondary study objective: to observe the safety of the test preparation and the reference preparation in healthy subjects.

The purpose of this study was to study the pharmacokinetic characteristics of aspirin enteric-coated tablets (100 mg) developed and produced by Chifeng Wanze Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using enteric-coated aspirin tablets (Bayaspirin®, 100 mg) certified by Bayer S.p.A and produced by Bayer HealthCare Manufacturing S.r.l. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.