NCT00689039已完成1 期
A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
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
- 94
- 试验地点
- 1
- 主要终点
- Adverse events, ECG, 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 and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
- •Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator
排除标准
- •ECG findings outside normal range
- •Potassium outside normal reference values
研究组 & 干预措施
A
Experimental
AZD1305 ER tablet
干预措施: AZD1305 (Drug)
B
Placebo Comparator
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events, ECG, 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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