NCT00684190已完成1 期
An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers
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
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent
- •Females no childbearing potential
- •Clinically normal physical findings
排除标准
- •Clinically significant illness within 2 weeks prior to the first dose of investigational product
- •History of clinically significant disease
- •Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
研究组 & 干预措施
1
Experimental
AZD3355 150 mg
干预措施: AZD3355 (Drug)
2
Experimental
Esomeprazole 40mg
干预措施: Esomeprazole (Drug)
3
Experimental
AZD3355 150mg/Esomeprazole 40mg
干预措施: AZD3355 (Drug)
3
Experimental
AZD3355 150mg/Esomeprazole 40mg
干预措施: Esomeprazole (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during day 7 each treatment period
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
- 4-BOH cholesterol(Sampling occasions during day 7 one treatment period (AZD3355 alone))
研究者
研究点 (1)
Loading locations...
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