NCT00736606已完成1 期
A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered 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
- 12
- 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 assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study specific procedures.
- •Male or female healthy subjects. Females should not be of childbearing potential
- •Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results
排除标准
- •Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
- •Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.
- •Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
研究组 & 干预措施
Period 1
Experimental
simvastatin
干预措施: simvastatin (Drug)
Period 2
Experimental
simvastatin + AZD9056
干预措施: AZD9056 + simvastatin (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during study periods
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment periods)
研究者
研究点 (1)
Loading locations...
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