NCT00406432已完成1 期
A Steady-state Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects
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 parameters
研究概览
简要总结
The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving paroxetine
Experimental
Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days.
干预措施: Paroxetine Controlled Release Tablet (Drug)
结局指标
主要结局
pharmacokinetic parameters
时间窗: Up to 21 days
次要结局
- safety parameters(adverse events, lab test results,vital signs,electrocardiograph)(Up to 21 days)
研究者
研究点 (1)
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