Beijing Huarui Dingxin Technology Co., Ltd

To evaluate the efficacy and safety of dextrabeprazole sodium for injection in the treatment of acute non-variceal upper gastrointestinal bleeding

This study aimed to investigate the pharmacokinetic characteristics of a single fasting and postprandial oral administration of cefixime granules (50 mg) developed by Beijing Huarui Dingxin Technology Co., Ltd. and produced by North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd.; using cefixime fine granules (Cefspan®, 50 mg) produced by Changshengtang Pharmaceutical Co., Ltd. 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.

To evaluate the pharmacokinetic characteristics of different doses of dexrabeprazole sodium for injection, as well as the effects on gastric pH of healthy volunteers, and to evaluate safety. To analyze the dose-effect correlation between the pharmacokinetic and pharmacodynamic parameters of dexrabeprazole sodium for injection, and to compare the pharmacokinetic exposure of dexrabeprazole sodium for injection, to explore the appropriate dose range of dexrabeprazole sodium for injection, and to provide a theoretical basis for later clinical trials.