NCT00549978已完成4 期
Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy 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
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters, Number of adverse events
研究概览
简要总结
to investigate the safety and pharmacokinetics, in healthy adult male subjects
详细描述
Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Gender: Male
- •Age: Over 20 and Under 40years, at time of informed consent
- •body weight: BMI over 19.0 and Under 25.0
- •Subjects who meet the following criteria at the time of the screening examination
- •Subjects who have given their written informed consent prior to participation in the study
- •Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol
排除标准
- •History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
- •Present or previous significant drug allergy to any prescription or over the counter medication
- •Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
- •Body weight: under 50Kg
研究组 & 干预措施
1
Other
Two compartments with cross-over and parallel
干预措施: Cilostazol (Drug)
2
Other
Two compartments with cross-over and parallel
干预措施: Probucol (Drug)
结局指标
主要结局
Pharmacokinetic parameters, Number of adverse events
时间窗: during study follow-up period
次要结局
- Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters(During study follow-up period)
研究者
研究点 (1)
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