Jilin Qijian Biotechnology Co., Ltd

The main purpose of the study is to study the pharmacokinetics of a single dose of the test preparation butylphthalide injection (specification: 5 ml: 25 mg, produced by Jilin Qijian Biotechnology Co., Ltd.) and the reference preparation butylphthalide sodium chloride injection (ENBIP®, specification: 100 ml: butylphthalide 25 mg and sodium chloride 0.9 g; produced by CSPC ENBIP Pharmaceutical Co., Ltd.) in healthy subjects, and to compare the bioavailability of the test preparation and the reference preparation after intravenous infusion in the fasting state. Secondary purpose of the study: to evaluate the safety of the test preparation butylphthalide injection (specification: 5 ml: 25 mg) and the reference preparation butylphthalide sodium chloride injection (ENBIP®, specification: 100 ml: butylphthalide 25 mg and sodium chloride 0.9 g) in healthy subjects.

Primary objective: To determine the plasma concentration of butylphthalide in healthy subjects after administration of butylphthalide sodium chloride injection produced by Jilin Qijian Biotechnology Co., Ltd. over time using a self-crossover design, and to estimate the corresponding pharmacokinetic parameters. The butylphthalide sodium chloride injection produced by CSPC Pharmaceutical Group Enbi Pharmaceutical Co., Ltd. (trade name: Enbi®, specification: 100 mL (butylphthalide 25 mg and sodium chloride 0.9 g)) was used as a reference to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the two butylphthalide sodium chloride injections in healthy Chinese subjects.