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Clinical Trials associated with ASKC141右旋硫辛酸氨丁三醇注射液治疗糖尿病周围神经病变患者的感觉异常II期临床试验
[Translation] Phase II clinical trial of dextrolipoic acid tromethamine injection in the treatment of paresthesia in patients with diabetic peripheral neuropathy
初步评价静脉滴注右旋硫辛酸氨丁三醇注射液治疗糖尿病周围神经病变患者的感觉异常的有效性和安全性,并与硫辛酸注射液(奥力宝)作比较。 探索静脉滴注不同剂量的右旋硫辛酸氨丁三醇注射液治疗糖尿病周围神经病变患者的感觉异常的有效性和安全性,并与硫辛酸注射液(奥力宝®)作比较。为 III期临床试验设计提供依据。
[Translation] To preliminarily evaluate the efficacy and safety of intravenous drip of dextrolipoic acid tromethamine injection in the treatment of sensory abnormalities in patients with diabetic peripheral neuropathy, and compare it with lipoic acid injection (Aolibao). To explore the efficacy and safety of intravenous drip of different doses of dextrolipoic acid tromethamine injection in the treatment of sensory abnormalities in patients with diabetic peripheral neuropathy, and compare it with lipoic acid injection (Aolibao®). To provide a basis for the design of Phase III clinical trials.
右旋硫辛酸氨丁三醇注射液与硫辛酸注射液在中国健康受试者中单次给药安全性及药代动力学对比研究
[Translation] Comparative study on the safety and pharmacokinetics of single-dose administration of dextrorotatory lipoic acid tromethamine injection and lipoic acid injection in Chinese healthy subjects
1. 以硫辛酸注射液为对照,考察右旋硫辛酸氨丁三醇注射液与硫辛酸注射液单次给药后体内右旋硫辛酸 PK 特征的一致性。 2. 获得中国健康受试者单次给予右旋硫辛酸氨丁三醇注射液后的药代参数,为后续临床试验的给药剂量提供依据。 3. 评价右旋硫辛酸氨丁三醇注射液单次给药后在中国健康受试者体内的安全性。
[Translation] 1. To investigate the consistency of the in vivo PK characteristics of dextrorotatory lipoic acid after a single administration of dextrorotatory lipoic acid tromethamine injection and lipoic acid injection, using lipoic acid injection as a control. 2. To obtain the pharmacokinetic parameters of dextrorotatory lipoic acid tromethamine injection in healthy Chinese subjects after a single administration, to provide a basis for the dosage of subsequent clinical trials. 3. To evaluate the safety of dextrorotatory lipoic acid tromethamine injection in healthy Chinese subjects after a single administration.
右旋硫辛酸氨丁三醇注射液在中国健康受试者中单/多次给药安全性及药代动力学研究
[Translation] Safety and pharmacokinetics of single/multiple administration of dextrolipoic acid tromethamine injection in Chinese healthy subjects
1. 评价右旋硫辛酸氨丁三醇注射液不同剂量单次给药后在中国健康受试者体内的耐受性和安全性; 2. 评价右旋硫辛酸氨丁三醇注射液多次给药后在中国健康受试者体内的耐受性和安全性; 3. 获得单/多次给予右旋硫辛酸氨丁三醇注射液后右旋硫辛酸在中国健康受试者体内的药代动力学(PK)参数,为后续临床试验给药剂量选择提供依据。
[Translation] 1. To evaluate the tolerability and safety of different doses of single administration of dextrolipoic acid tromethamine injection in healthy Chinese subjects; 2. To evaluate the tolerability and safety of dextrolipoic acid tromethamine injection in healthy Chinese subjects after multiple administrations; 3. To obtain the pharmacokinetic (PK) parameters of dextrolipic acid in healthy Chinese subjects after single/multiple administrations of dextrolipoic acid tromethamine injection, and provide a basis for the selection of dosage in subsequent clinical trials.
100 Clinical Results associated with ASKC141
100 Translational Medicine associated with ASKC141
100 Patents (Medical) associated with ASKC141
100 Deals associated with ASKC141