NCT01115946已完成1 期
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -
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
- 24
- 主要终点
- Plasma concentration of enalapril
研究概览
简要总结
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight: =<50.0kg, <80.0kg
- •Body mass index: =<17.6, <26.4
- •Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data
排除标准
- •Attending another clinical trial within 120 days before the study
- •Blood donation within 90 days (400ml) or 30 days (200ml) before the study
- •Receiving any drugs within 7 days before the study
- •History of allergy to drugs
- •Having GI disorders
- •History or complication of liver diseases
- •History or complication of heart disease
- •History or complication of respiratory diseases
- •History or complication of renal diseases
- •History or complication of cerebrovascular diseases
研究组 & 干预措施
single-add first group
Experimental
single administration first, then concomitant administration
干预措施: ASP1585 (Drug)
single-add first group
Experimental
single administration first, then concomitant administration
干预措施: enalapril (Drug)
combi-add first group
Experimental
concomitant administration first, then single administration
干预措施: ASP1585 (Drug)
combi-add first group
Experimental
concomitant administration first, then single administration
干预措施: enalapril (Drug)
结局指标
主要结局
Plasma concentration of enalapril
时间窗: for 48 hours after administration
次要结局
- Safety assessed by AE, vital signs 12-lead ECG and lab tests(for 7 days after administration)
研究者
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