NCT00688831已完成1 期
A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty 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
- 36
- 试验地点
- 1
- 主要终点
- Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
研究概览
简要总结
The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •BIM 19-30 kg/m2
排除标准
- •Potassium outside normal reference values
- •ECG findings outside normal range
研究组 & 干预措施
A
Experimental
AZD1305 solution for iv infusion
干预措施: AZD1305 (Drug)
B
Placebo Comparator
NaCl solution for iv infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
时间窗: During the study
次要结局
- Pharmacokinetic variables(During all dosing visits)
研究者
研究点 (1)
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