NCT00752830已完成1 期
A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects
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
- 14
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Caucasian subjects.
- •Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
- •Signed informed consent form
排除标准
- •History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
- •Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.
研究组 & 干预措施
1
Experimental
AZD0328 administration during fasting condition
干预措施: AZD0328 (Drug)
2
Experimental
AZD0328 administration after food intake
干预措施: AZD0328 (Drug)
结局指标
主要结局
PK variables
时间窗: Several PK samples during the study days
次要结局
- Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)(During the whole treatment period)
研究者
研究点 (1)
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