Hebei Zhiheng Pharmaceutical Co., Ltd.

Primary Objective: In accordance with relevant bioequivalence testing regulations, metformin hydrochloride extended-release tablets (trade name: Glucophage XR, specification: 0.5g), manufactured by Merck Pharmaceuticals (Jiangsu) Co., Ltd., was selected as the reference formulation. A human bioequivalence study was conducted on the test formulation, metformin hydrochloride extended-release tablets (specification: 0.5g), manufactured by Zhejiang Jingxin Pharmaceutical Co., Ltd. and provided by Hebei Zhiheng Pharmaceutical Technology Co., Ltd., under fasting and postprandial administration conditions. The study compared the absorption rate and extent of absorption of the drug in the test formulation with those in the reference formulation to determine if the differences were within acceptable limits, and evaluated the bioequivalence of the two formulations under fasting and postprandial administration conditions. Secondary Objective: To observe the safety of oral administration of the test formulation, metformin hydrochloride extended-release tablets (specification: 0.5g), and the reference formulation, metformin hydrochloride extended-release tablets (trade name: Glucophage XR, specification: 0.5g), in healthy participants.

Main research purpose: According to the relevant provisions of bioequivalence test, dapagliflozin metformin sustained-release tablets (Ⅰ) (trade name: Xigduo XR (Anda Shi®), specification: 10mg/1000mg) with AstraZeneca AB as the licensee was selected as the reference preparation, and the test preparation dapagliflozin metformin sustained-release tablets (Ⅰ) (specification: 10mg/1000mg) produced by Shijiazhuang Longze Pharmaceutical Co., Ltd. and provided by Hebei Zhiheng Pharmaceutical Technology Co., Ltd. was subjected to fasting and fed human bioequivalence test, 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 fasting and fed conditions. Secondary study objective: To observe the safety of oral administration of the test preparation dapagliflozin metformin sustained-release tablets (I) (specification: 10 mg/1000 mg) and the reference preparation dapagliflozin metformin sustained-release tablets (I) (trade name: Xigduo XR (Anda Shi®), specification: 10 mg/1000 mg) to healthy subjects.

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.