Hebei Zhiheng Pharmaceutical Co., Ltd.

Main purpose: According to the relevant provisions of bioequivalence test, the pediatric faropenem sodium granules (trade name: Feroum, specification: 0.05g (calculated as C12H15NO5S)) of Maruho Co., Ltd as the licensee was selected as the reference preparation, and the test preparation pediatric faropenem sodium granules (specification: 0.05g (calculated as C12H15NO5S) produced by Hunan Jiudian Pharmaceutical Co., Ltd. and provided by Hebei Zhiheng Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence test under fasting and postprandial administration conditions, and the pharmacokinetic characteristics of the test preparation and the reference preparation were compared, and the bioequivalence of the two preparations under fasting or postprandial administration conditions was evaluated. Secondary objective: To observe the safety of oral administration of the test preparation, Faropenem Sodium Granules for Children (Specification: 0.05g (calculated as C12H15NO5S)) and the reference preparation, Faropenem Sodium Granules for Children (trade name: Feromu, specification: 0.05g (calculated as C12H15NO5S)) to healthy subjects. To evaluate the palatability of Faropenem Sodium Granules for Children in healthy Chinese subjects and provide a basis for the taste of Faropenem Sodium Granules for Children.

Main purpose of study: According to the provisions of the bioequivalence test, dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10 mg) produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd. and licensed by Hebei Zhiheng Pharmaceutical Technology Co., Ltd. were tested in human body under the conditions of fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under the conditions of fasting and postprandial administration. Secondary purpose of study: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: FORXIGA, specification: 10 mg) to healthy subjects.

A single-center, randomized, open, four-period completely repeated crossover, single-dose, fasting and post-meal administration design was used to evaluate the bioequivalence of fasting and post-meal oral administration in healthy people, providing evidence for the consistency of clinical efficacy of sofosbuvir tablets produced by Beijing Kaingeling Biotechnology Co., Ltd. and sofosbuvir tablets produced by Gilead Sciences International Ltd.