评估Cenobamate添加治疗癫痫部分性发作受试者疗效与安全性的随机、双盲、安慰剂对照、多中心研究,含可选开放性扩展部分
[Translation] A randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of add-on Cenobamate in subjects with partial-onset seizures, with optional open-label extension
主要目的:评估Cenobamate 作为添加治疗与安慰剂相比对POS受试者的疗效。
次要目的:
评估Cenobamate 治疗POS受试者的安全性与耐受性。
评估Cenobamate 治疗POS和指定癫痫类型的作用。
测定POS受试者的Cenobamate 血浆浓度。
[Translation] Main objective: To evaluate the efficacy of Cenobamate as an add-on treatment compared to placebo in subjects with POS.
Secondary purpose:
To evaluate the safety and tolerability of Cenobamate in subjects with POS.
To evaluate the effect of Cenobamate in the treatment of POS and assigned epilepsy types.
Cenobamate plasma concentrations were determined in POS subjects.
一项评估单剂量口服cenobamate在中国健康受试者体内的药代动力学和安全性的I期单中心、随机、双盲、安慰剂对照研究
[Translation] A phase I single-center, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics and safety of single-dose oral cenobamate in healthy Chinese subjects
本研究的主要目的是描述健康中国受试者单剂口服 Cenobamate 后的 Cenobamate 药代动力学(PK)特征。
本研究的次要目的是评估健康中国受试者单剂口服 Cenobamate 的安全性。
[Translation] The primary objective of this study was to characterize the pharmacokinetics (PK) of Cenobamate following a single oral dose of Cenobamate in healthy Chinese subjects.
The secondary objective of this study was to evaluate the safety of a single dose of oral Cenobamate in healthy Chinese subjects.
100 Clinical Results associated with SK Bio-Pharma Tech (Shanghai) Co., Ltd.
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