NCT00489606已完成1 期
Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers
适应症
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
- 2
- 主要终点
- Maximal decrease from baseline in supine SBP
研究概览
简要总结
To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.
详细描述
During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •ages 20 to 50
- •body weight of IBM±20%
排除标准
- •cardiovascular disease
- •color-blindness or weakness
- •hypotension, hypertension, orthostatic hypertension
- •abmormal QTc (>430 ms)
结局指标
主要结局
Maximal decrease from baseline in supine SBP
时间窗: within 6 hrs after SK3530 or placebo
次要结局
- Maximal decrease from baseline in standing SBP, supine/standing DBP & HR(within 6 hrs after SK3530 or placebo)
- Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg(within 6 hrs after SK3530 or placebo)
- Incidence of postural hypotension(within 6 hrs after SK3530 or placebo)
研究者
研究点 (2)
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