NCT01676571已完成1 期
A Single-centre, Open-label, Single-dose Interventional Study Investigating the Pharmacokinetic Properties of Lu AA21004 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
- 16
- 试验地点
- 1
- 主要终点
- PK AUC determination of Lu AA21004 (Vortioxetine)
研究概览
简要总结
The rationale for this pharmacokinetic (PK) study is to determine the PK parameters for Lu AA21004 (Vortioxetine) in the Chinese population.
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
Lu AA21004
Experimental
干预措施: Lu AA21004 (Drug)
结局指标
主要结局
PK AUC determination of Lu AA21004 (Vortioxetine)
时间窗: 11 days
Area under the curve (AUC)
PK Cmax determination of Lu AA21004 (Vortioxetine)
时间窗: 11 days
Maximum observed concentration (Cmax)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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