NCT00914303已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect
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
- 77
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, ECG, safety lab)
研究概览
简要总结
The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects 30-65 years
- •Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
排除标准
- •History of any clinically significant disease or disorder
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Previous history of frequent pre-syncope or syncope
研究组 & 干预措施
AZD3241
Experimental
AZD3241 Tablets
干预措施: AZD3241 (Drug)
Placebo
Experimental
Placebo Tablets
干预措施: Placebo Tablet (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, ECG, safety lab)
时间窗: Assessments performed at frequent timepoints during a 4-8 week period
次要结局
- To characterize the pharmacokinetics of AZD3241 in plasma(Frequent sampling occasions during some study days for a 4-8 weeks period)
研究者
研究点 (1)
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