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MechanismGABAB receptor modulators [+2] |
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Inactive Indication- |
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] Single- and multiple-dose pharmacokinetic clinical trials of PXT3003 in Chinese healthy 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 research purposes:
The metabolic processes of (RS)-baclofen and naltrexone hydrochloride in Chinese healthy subjects were observed after single and multiple oral administration of PXT3003, and the corresponding pharmacokinetic parameters were calculated.
Secondary research purposes:
To observe the safety of PXT3003 in Chinese healthy 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 evaluating the efficacy and safety of PXT3003 in the treatment of type 1A peroneal muscular dystrophy 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] Main research purposes:
The 15-month efficacy of PXT3003 in the treatment of peroneal muscular dystrophy type 1A (CMT1A) was assessed by the Global Neurological Limitation Scale (ONLS).
Secondary research purposes:
The efficacy of PXT3003 was assessed by functional tests, electrophysiological parameters and quality of life parameters; the safety of PXT3003 was assessed.
100 Clinical Results associated with Tasly International Gene Network Drug Innovation Center Co., Ltd.
0 Patents (Medical) associated with Tasly International Gene Network Drug Innovation Center Co., Ltd.
100 Deals associated with Tasly International Gene Network Drug Innovation Center Co., Ltd.
100 Translational Medicine associated with Tasly International Gene Network Drug Innovation Center Co., Ltd.