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MechanismGABAB receptor modulators [+2] |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
PXT3003在中国健康受试者中单次及多次给药的药代动力学临床试验
[Translation] Clinical trial of single and multiple dose pharmacokinetic data of PXT3003 in healthy Chinese subjects
主要研究目的:
观察PXT3003单次及多次口服给药后(RS)-巴氯酚、盐酸纳曲酮在中国健康受试者体内的代谢过程,计算相应的药代动力学参数。
次要研究目的:
观察PXT3003在中国健康受试者中的安全性。
[Translation] Main study objectives:
To observe the metabolism of (RS)-baclofen and naltrexone hydrochloride in healthy Chinese subjects after single and multiple oral administration of PXT3003, and to calculate the corresponding pharmacokinetic parameters.
Secondary study objectives:
To observe the safety of PXT3003 in healthy Chinese subjects.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy and Safety of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A) Treated 15 Months
This is a randomized, double-blind, placebo-controlled and multicenter 3 phase trial evaluating the therapeutic effect and safety of CMT1A by PXT3003. This double-blind study will assess in parallel groups 1 dose of PXT3003 compared to Placebo in CMT1A patients treated for 15 months.
评估PXT3003治疗1A型腓骨肌萎缩症15个月的疗效和安全性的多中心、随机、双盲、安慰剂对照III期临床试验
[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of PXT3003 in the treatment of Charcot-Marie-Tooth Disease Type 1A for 15 months
主要研究目的:
通过总体神经功能限制量表(ONLS)评估PXT3003治疗1A型腓骨肌萎缩症(CMT1A)15个月的有效性。
次要研究目的:
通过功能学检测、电生理参数和生活质量参数评估PXT3003的有效性;评估PXT3003的安全性。
[Translation] Primary study objectives:
To evaluate the 15-month efficacy of PXT3003 in the treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A) using the Overall Neurological Limitation Scale (ONLS).
Secondary study objectives:
To evaluate the efficacy of PXT3003 using functional tests, electrophysiological parameters, and quality of life parameters; to evaluate the safety of PXT3003.
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