丁苯酞氯化钠注射液在中国健康受试者中的一项单中心、随机、开放、两周期、双交叉空腹状态下生物等效性试验
[Translation] A single-center, randomized, open-label, two-cycle, double-crossover fasting bioequivalence trial of butylphthalide sodium chloride injection in Chinese healthy subjects
主要目的:
以药代动力学参数作为主要终点评价指标,比较在空腹状态下静脉输注受试制剂丁苯酞氯化钠注射液(江西千湖药业集团有限公司持证,江西科伦药业有限公司生产,规格:100ml:丁苯酞25mg与氯化钠0.9g,受试制剂T)与参比制剂丁苯酞氯化钠注射液(石药集团恩必普药业有限公司持证并生产,商品名:恩必普®,规格:100ml:丁苯酞25mg与氯化钠0.9g,参比制剂R)后在健康受试者体内的药代动力学行为,评价受试制剂和参比制剂在健康人体的生物等效性。
次要目的:
观察受试制剂丁苯酞氯化钠注射液和参比制剂丁苯酞氯化钠注射液在中国健康受试者中的安全性。
[Translation] main purpose:
Pharmacokinetic parameters were used as the primary endpoint evaluation index to compare intravenous infusion of the test preparation Butylphthalide Sodium Chloride Injection (licensed by Jiangxi Qianhu Pharmaceutical Group Co., Ltd., Jiangxi Kelun Pharmaceutical Co., Ltd.) in the fasting state. Production, specifications: 100ml: 25 mg butylphthalide and 0.9g sodium chloride, test preparation T) and reference preparation butylphthalide sodium chloride injection (certified and produced by CSPC Enbipu Pharmaceutical Co., Ltd., Trade name: Enbipu®, Specification: 100ml: Pharmacokinetic behavior in healthy subjects after adding 25 mg butylphthalide and 0.9 g sodium chloride, reference preparation R) to evaluate the test preparation and reference preparation Bioequivalence in healthy humans.
Secondary purpose:
To observe the safety of the test preparation Butylphthalide Sodium Chloride Injection and the reference preparation Butylphthalide Sodium Chloride Injection in Chinese healthy subjects.
100 Clinical Results associated with Jiangxi Qianhu Pharmaceutical Technology Development Co., Ltd.
0 Patents (Medical) associated with Jiangxi Qianhu Pharmaceutical Technology Development Co., Ltd.
100 Deals associated with Jiangxi Qianhu Pharmaceutical Technology Development Co., Ltd.
100 Translational Medicine associated with Jiangxi Qianhu Pharmaceutical Technology Development Co., Ltd.