Shanghai Jincheng Pharmaceutical Co. Ltd.

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.

Primary objective: To study the pharmacokinetic behavior of cefadroxil in healthy Chinese subjects after single oral administration of the test formulation of cefadroxil dry suspension (500mg/5mL, Shanghai Jincheng Suzhi Pharmaceutical Co., Ltd.) and the reference formulation of cefadroxil dry suspension (500mg/5mL, licensee: LUPIN LTD) on an empty stomach and after a meal, and to evaluate the bioequivalence of the two formulations in the empty stomach and after a meal. Secondary objective: To evaluate the safety of the test formulation and reference formulation of cefadroxil dry suspension in healthy Chinese subjects after single oral administration on an empty stomach and after a meal.