Shanghai Jincheng Pharmaceutical Co. Ltd.

Main study objectives: To investigate the relative bioavailability of a single oral dose of 250 mg (fasting/after meals) of the test preparation, pediatric cefuroxime axetil dry suspension (microsphere type) (specification: 125 mg [in terms of cefuroxime], produced by Wentao Innovative Drug Research (Beijing) Co., Ltd.) and the reference preparation, cefuroxime axetil dry suspension (trade name: Zinnat, specification: 125 mg/5 mL [in terms of cefuroxime], produced by Glaxo WeLLCome UK Limited) in healthy Chinese subjects, 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 drug. Secondary study objectives: To evaluate the safety of a single oral dose of 250 mg (fasting/after meals) of the test preparation and the reference preparation in healthy Chinese adult subjects.

The cephalexin dry suspension produced by Shanghai Jincheng Suzhi Pharmaceutical Co., Ltd. was used as the test preparation, and the cephalexin dry suspension certified by Flynn Pharma Ltd was used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation cefaclor dispersible tablets (manufacturer: Shanghai Jincheng Suzhi Pharmaceutical Co., Ltd.) and the reference preparation cefaclor dry suspension (manufacturer: Suzhou Xikro Pharmaceutical Co., Ltd., trade name: Xikro®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation cefaclor dispersible tablets and the reference preparation cefaclor dry suspension in healthy subjects.