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评价丹参素钠注射液治疗冠状动脉微血管疾病的有效性和安全性的多中心、随机、
开放、平行对照设计的 IIa 期临床研究
[Translation] A multicenter, randomized, open, parallel controlled phase IIa clinical study to evaluate the efficacy and safety of Danshensu sodium injection in the treatment of coronary microvascular disease
评价丹参素钠注射液治疗冠状动脉微血管疾病的有效性及安全性
[Translation] To evaluate the efficacy and safety of Danshensu sodium injection in the treatment of coronary microvascular disease
丹参素钠注射液在中国健康志愿者中多次给药的安全性、耐受性和药代动力学I期临床研究
[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of multiple-dose danshensu sodium injection in Chinese healthy volunteers
(1)评价丹参素钠注射液在中国健康志愿者中多次静脉滴注的安全性和耐受性,确定丹参素钠注射液的安全剂量范围,为后续临床开发提供参考;
(2)评价丹参素注射液在中国健康志愿者中多次静脉滴注的药代动力学特征。
[Translation] (1) To evaluate the safety and tolerability of multiple intravenous infusions of Danshensu sodium injection in healthy Chinese volunteers, determine the safe dosage range of Danshensu sodium injection, and provide a reference for subsequent clinical development;
(2) To evaluate the pharmacokinetic characteristics of multiple intravenous infusions of Danshensu sodium injection in healthy Chinese volunteers.
丹参素钠注射液在中国健康志愿者中单次给药的安全性、耐受性和药代动力学I期临床研究
[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of single-dose danshensu sodium injection in Chinese healthy volunteers
主要目的: 1)评价丹参素钠注射液在健康受试者中单次给药的安全性和耐受性,确定最大耐受剂量,为多次给药耐受性试验提供依据。 2)考察丹参素钠注射液在健康受试者中单次给药的药代动力学特征。 次要目的:为后期的临床试验推荐剂量;安全和合理的静滴速度。
[Translation] Main objectives: 1) To evaluate the safety and tolerability of single-dose danshensu sodium injection in healthy subjects, determine the maximum tolerated dose, and provide a basis for multiple-dose tolerance tests. 2) To investigate the pharmacokinetic characteristics of single-dose danshensu sodium injection in healthy subjects. Secondary objectives: To recommend doses for later clinical trials; safe and reasonable intravenous drip rates.
100 Clinical Results associated with Shenzhen Gaoyingtai Technology Development Co., Ltd.
0 Patents (Medical) associated with Shenzhen Gaoyingtai Technology Development Co., Ltd.
100 Deals associated with Shenzhen Gaoyingtai Technology Development Co., Ltd.
100 Translational Medicine associated with Shenzhen Gaoyingtai Technology Development Co., Ltd.