Nanchang Lijian Pharmaceutical Co. Ltd.

Main purpose of the study: According to the relevant provisions of bioequivalence tests, the metformin empagliflozin tablets (trade name: Synjardy®, specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) of Boehringer Ingelheim Pharmaceuticals Inc as the licensee were selected as the reference preparation, and the test preparation metformin empagliflozin tablets (VI) (specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) produced and provided by Nanchang Lijian Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence tests 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 study objective: To observe the safety of oral administration of the test preparation metformin empagliflozin tablets (VI) (specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) and the reference preparation metformin empagliflozin tablets (trade name: Synjardy®, specification: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) to healthy volunteers.

The main purpose of the study is to study the pharmacokinetics of the test preparation Sitagliptin Metformin Tablets (II) (Specifications: 50 mg/850 mg, produced by Nanchang Lijian Pharmaceutical Co., Ltd.) and the reference preparation Sitagliptin Metformin Tablets (II) (trade name: Jeroda®, specifications: 50 mg/850 mg; produced by Patheon Puerto Rico, Inc. (Manati)) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. The secondary purpose of the study is to evaluate the safety of the test preparation Sitagliptin Metformin Tablets (II) (Specifications: 50 mg/850 mg) and the reference preparation Jeroda® (Specifications: 50 mg/850 mg) in healthy subjects.

Sildenafil citrate tablets produced by Nanchang Lijian Pharmaceutical Company were used as the test preparation, and Sildenafil citrate tablets (Viagra ®) produced by Pfizer Pharmaceuticals LLC were used as the reference preparation. The differences in the absorption rate and extent of a single dose of the two preparations in healthy humans after a meal were investigated, and the relative bioavailability between the two preparations was calculated to evaluate whether the two preparations were bioequivalent after a meal.