NCT00707551已完成1 期
A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young 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
- 27
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables
研究概览
简要总结
The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •A body mass index (BMI=weight/height2) of 19 to 30 kg/m2
排除标准
- •Potassium outside normal reference values
- •ECG findings outside normal range
研究组 & 干预措施
1
Experimental
Ketoconazole tablet + AZD1305 Extended Release tablet
干预措施: Ketoconazole (Drug)
1
Experimental
Ketoconazole tablet + AZD1305 Extended Release tablet
干预措施: AZD1305 (Drug)
2
Experimental
Verapamil Extended Release tablet + AZD1305 Extended Release tablet
干预措施: Verapamil (Drug)
2
Experimental
Verapamil Extended Release tablet + AZD1305 Extended Release tablet
干预措施: AZD1305 (Drug)
3
Experimental
AZD1305 Extended Release tablet
干预措施: AZD1305 (Drug)
结局指标
主要结局
Pharmacokinetic variables
时间窗: During all dosing visits
次要结局
- Adverse events, vital signs, ECG, laboratory variables and physical examination(During the study)
研究者
研究点 (1)
Loading locations...
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