NCT00813306已完成1 期
A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy 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
- 40
- 试验地点
- 1
- 主要终点
- Manometry
研究概览
简要总结
The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written consent prior to any study specific procedures.
- •Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
- •Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.
排除标准
- •Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
- •A measured LES pressure of < 5mm Hg.
- •History of previous or ongoing psychiatric disease/condition.
研究组 & 干预措施
A
Experimental
AZD2066
干预措施: AZD2066 (Drug)
B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
C
Experimental
AZD2066
干预措施: AZD2066 (Drug)
D
Experimental
AZD2066
干预措施: AZD2066 (Drug)
E
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Manometry
时间窗: 3.45 hours each study period
次要结局
- pH(3.45 hours each study period)
- Impedance(3.45 hours each study period)
- Pharmacokinetic variables(3.45 hours each study period)
研究者
研究点 (1)
Loading locations...
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