[Translation] Study on the bioequivalence of sodium chloride butylphthalide injection in healthy volunteers
主要目的:以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定吉林省奇健生物技术有限公司的丁苯酞氯化钠注射液给药后血浆中的丁苯酞在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以石药集团恩必普药业有限公司持证生产的丁苯酞氯化钠注射液〔商品名:恩必普®,规格:100 mL(丁苯酞25 mg与氯化钠0.9 g)〕为参比,评价两种制剂的生物等效性。次要目的:观察两种丁苯酞氯化钠注射液在中国健康受试者中的安全性。
[Translation] 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.
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