Shanghai Haihong Industrial Group Chaohu Jinchen Pharmaceutica

Main research purpose: According to the relevant provisions of bioequivalence test, metformin empagliflozin tablets (trade name: SYNJARDY, specification: 500mg+5mg) with BOEHRINGER INGEL HEIM PTY LTD as the licensee were selected as the reference preparation, and the test preparation metformin empagliflozin tablets (specification: 500mg+5mg) produced and provided by Shanghai Haihong Industrial (Group) Chaohu Jinchen Pharmaceutical Co., Ltd. were subjected to human bioequivalence test for 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 fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation metformin empagliflozin tablets (specification: 500mg+5mg) and the reference preparation metformin empagliflozin tablets (trade name: SYNJARDY, specification: 500mg+5mg) in healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, GlaxoSmithkline K.K. is the licensee of amoxicillin and clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, specification: 642.9mg (1.01g)) as the reference preparation, and the test preparation amoxicillin and clavulanate potassium (14:1) dry suspension (specification: 0.643g (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) produced by Shanghai Haihong Industrial (Group) Chaohu Jinchen Pharmaceutical Co., Ltd. is used for postprandial human bioequivalence test, compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation amoxicillin clavulanate potassium (14:1) dry suspension (specification: 0.643g (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) and the reference preparation amoxicillin clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, specification: 642.9mg (1.01g)) to healthy volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, GlaxoSmithkline K.K. is selected as the reference preparation of amoxicillin clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, specification: 642.9mg (1.01g)), and the test preparation amoxicillin clavulanate potassium (14:1) dry suspension (specification: 0.643g (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) produced by Shanghai Haihong Industrial (Group) Chaohu Jinchen Pharmaceutical Co., Ltd. is conducted on the human bioequivalence test of fasting administration, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation amoxicillin clavulanate potassium (14:1) dry suspension (specification: 0.643g (C16H19N3O5S 0.6g and C8H9NO5 0.043g)) and the reference preparation amoxicillin clavulanate potassium dry syrup (14:1) (trade name: クラバモックス®, specification: 642.9mg (1.01g)) to healthy volunteers.