NCT01000467已完成4 期
A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
研究概览
简要总结
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.
详细描述
To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 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
3
Active Comparator
Group 3(Probucol 500mg once daily)
干预措施: probucol (Drug)
2
Active Comparator
Group 2(probucol 500mg BID)
干预措施: probucol (Drug)
1
Active Comparator
Group 1(Probucol 250mg)
干预措施: probucol (Drug)
结局指标
主要结局
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
时间窗: 1 month
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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