An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Relative bioavailability of AZD9056 using PK variables Cmax and AUC
研究概览
简要总结
The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Provision of informed consent prior to any study-specific procedures
- •Healthy Volunteers, Females should not be of childbearing potential
- •BMI between 18 and 30 kg/m2
排除标准
- •Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
- •A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
- •Known or suspected drug or alcohol abuse or positive DOA test
研究组 & 干预措施
1
50 or 400 mg AZD9056, Test formulation
干预措施: AZD9056 formulation Phase III 50 mg (T) (Drug)
1
50 or 400 mg AZD9056, Test formulation
干预措施: AZD9056 formulation Phase III 200 mg (T) (Drug)
2
50 or 400 mg AZD9056, Reference formulation
干预措施: AZD9056 formulation Phase IIb 50 mg (R) (Drug)
2
50 or 400 mg AZD9056, Reference formulation
干预措施: AZD9056 formulation Phase IIb 200mg (R) (Drug)
结局指标
主要结局
Relative bioavailability of AZD9056 using PK variables Cmax and AUC
时间窗: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
次要结局
- Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)(For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7)
- Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)(Frequent sampling occasions throughout the study period)