NCT01324752已完成1 期
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Losartan Potassium in Healthy Male and Female Adults
Vifor Pharma1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Effect of PA21 on Losartan potassium
研究概览
简要总结
The purpose of this study is to determine if Losartan potassium is affected by PA21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Written informed consent
排除标准
- •No significant medical conditions
- •Pregnancy
研究组 & 干预措施
PA21 and Losartan with food
Experimental
干预措施: PA21 and Losartan with Food (Drug)
No PA21; Losartan with food
Experimental
干预措施: No PA21; Losartan with food (Drug)
PA21 with food and Losartan 2 hrs later
Experimental
干预措施: PA21 with food and Losartan 2 hours later (Drug)
结局指标
主要结局
Effect of PA21 on Losartan potassium
时间窗: PK assessment on Day 0, 11, 22
To assess the effect, if any, of PA21 on Losartan potassium exposure
次要结局
- Effect of PA21 on the active metabolite of Losartan potassium(PK assessment on Day 0, 11, 22)
研究者
研究点 (1)
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