NCT01652313已完成1 期
A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
研究概览
简要总结
The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is a Chinese man or woman
- •The subject is, in the opinion of the investigator, generally healthy
- •If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
排除标准
- •The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Rasagiline
Experimental
干预措施: Rasagiline (Drug)
结局指标
主要结局
Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
时间窗: 7 days
PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)
时间窗: 7 days
次要结局
- Number of patients with adverse events as a measure of safety and tolerability(7 days)
研究者
研究点 (1)
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