Changzhou Sunlight Pharmaceutical Co. Ltd.

To investigate the pharmacokinetic characteristics of a single oral dose of metformin empagliflozin tablets (I) (test preparation, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) provided by Changzhou Sunshine Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, and a single oral dose of metformin empagliflozin tablets (I) (reference preparation, trade name: Synjardy®, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) certified by Boehringer Ingelheim Pharmaceuticals Inc. under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

This study investigated the pharmacokinetic characteristics of a single oral administration of felodipine sustained-release tablets (test preparation, specification: 5 mg) produced by Changzhou Sunshine Pharmaceutical Co., Ltd. or felodipine sustained-release tablets (reference preparation, trade name: Plendil®, specification: 5 mg) certified by AstraZeneca Pharmaceuticals Co., Ltd. under fasting and postprandial conditions in healthy subjects, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.

Main research objectives To study the pharmacokinetic characteristics of a single oral administration of metformin empagliflozin tablets (VI) (test preparation, specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) provided by Changzhou Sunshine Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of metformin empagliflozin tablets (VI) (reference preparation, trade name: Synjardy®, specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) certified by Boehringer Ingelheim Pharmaceuticals Inc. under the same conditions, to evaluate the bioequivalence between the two preparations, and to provide a basis for the registration application of the test preparation. Secondary study objectives: To observe the safety of a single oral administration of one tablet of the test preparation metformin empagliflozin tablet (VI) (specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) and one tablet of the reference preparation metformin empagliflozin tablet (VI) (trade name: Synjardy®, specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) to healthy subjects under fasting and postprandial conditions.