Erythema Nodosum

Main study objectives Healthy subjects were given a single oral dose of the test preparation ibuprofen granules (specification: 0.2g) produced by Shandong Zibo Xinda Pharmaceutical Co., Ltd. or the reference preparation ibuprofen granules (specification: 20%1g, trade name: Brufen ®) produced by Kaken Pharmaceutical Co., Ltd. in the fasting or postprandial state, respectively, to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in the healthy subjects in the fasting or postprandial state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives Investigate the safety of the test preparation and the reference preparation in healthy subjects.

The ibuprofen granules (specification: 200 mg/g) developed by Jilin Kaiman Pharmaceutical Co., Ltd. were used as the test preparation, and the ibuprofen granules (trade name: Brufen®, specification: 200 mg/g) of the licensee Kaken Pharmaceutical Co., Ltd were used as the reference preparation. 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.