NCT00975754已完成1 期
A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices
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
- Lung deposition of budesonide (AUC)
研究概览
简要总结
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.
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 45 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
- •BMI between 18 and 30 kg/m2
- •Non-smokers/non-snuffers
排除标准
- •Pregnant and/or lactating women
- •Use of oral contraceptives or hormonal implants
- •Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs
研究组 & 干预措施
1
Experimental
Pulmicort pMDI
干预措施: Pulmicort pMDI HFA (Drug)
2
Experimental
Budesonide pMDI
干预措施: Budesonide pMDI HFA (Drug)
3
Experimental
Budesonide pMDI + Aerochamber Zero-stat spacer
干预措施: Budesonide pMDI HFA (Drug)
4
Experimental
Pulmicort repulses via Spira Nebuliser
干预措施: Pulmicort Repulses (Drug)
5
Experimental
Pulmicort Turbohaler
干预措施: Pulmicort Turbohaler (Drug)
结局指标
主要结局
Lung deposition of budesonide (AUC)
时间窗: Before dose and repeatadly during the 8-hour period after dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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