NCT01311635已完成1 期
A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential
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
- 16
- 试验地点
- 1
- 主要终点
- Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
研究概览
简要总结
The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
- •Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
- •Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
- •Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
- •Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
- •History of, or current alcohol or drug abuse
研究组 & 干预措施
Treatment A
Experimental
干预措施: AZD1981, current small-particle tablet (Drug)
Treatment B
Experimental
干预措施: AZD1981, new small-particle tablet (Drug)
Treatment C
Experimental
干预措施: AZD1981, new small-particle tablet (Drug)
Treatment D
Experimental
干预措施: AZD1981, new large-particle table (Drug)
结局指标
主要结局
Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981
时间窗: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.
次要结局
- To evaluate basic systemic PK parameters as follows:(PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period)
- To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight(Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study)
研究者
研究点 (1)
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