Nanjing Han Xin Pharmaceutical Technology Co., Ltd.

Primary objective: To evaluate the safety and tolerability of AC02 for injection after single/multiple administration in healthy subjects. Secondary objectives: To evaluate the pharmacokinetic and pharmacodynamic characteristics of AC02 for injection after single/multiple administration in healthy subjects; To evaluate the immunogenicity characteristics of AC02 for injection after single/multiple administration in healthy subjects; To evaluate the effect of AC02 for injection on the QTc interval in healthy subjects.

Amoxicillin-clavulanate potassium dry suspension produced by Nanjing Chengong Pharmaceutical Co., Ltd. was used as the test preparation, and amoxicillin-clavulanate potassium dry suspension produced by SmithKline Beecham Limited was used as the reference preparation. The bioequivalence of the two preparations in humans was evaluated through a single-center, randomized, open-label study.

The main purpose of the study is to use the dapagliflozin metformin extended-release tablets of Nanjing Hanxin Pharmaceutical Technology Co., Ltd. as the test preparation and the dapagliflozin metformin extended-release tablets (trade name: Xigduo XR) certified by AstraZeneca AB as the reference preparation, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-period crossover design. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.