NCT01254461已完成1 期
A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male 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
- Pharmacokinetics for pravastatin measured by Cmax and AUC
研究概览
简要总结
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18 to 55, inclusive
- •Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive
- •Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
- •Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings in physical examination
研究组 & 干预措施
A
Experimental
干预措施: AZD1981 (Drug)
A
Experimental
干预措施: pravastatin (Drug)
B
Experimental
干预措施: AZD1981 (Drug)
B
Experimental
干预措施: pravastatin (Drug)
结局指标
主要结局
Pharmacokinetics for pravastatin measured by Cmax and AUC
时间窗: Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B
Pharmacokinetics for pravastatin measured by Cmax and AUC
次要结局
- AUC(PK sampling will be performed on Day 1, period A and on Day 7-8, period B)
- AUCτ(PK sampling will be performed on Day 7 and Day 8, period B)
- Safety and tolerability(Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study)
研究者
研究点 (1)
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