NCT00620620已完成1 期
Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health
排除标准
- •Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
研究组 & 干预措施
Inhaled Placebo
Placebo Comparator
Staccato Placebo
干预措施: Inhaled placebo (Drug)
Inhaled Zaleplon 0.5 mg
Experimental
Staccato Zaleplon 0.5 mg
干预措施: Inhaled Zaleplon 0.5 mg (Drug)
Inhaled Zaleplon 1 mg
Experimental
Staccato Zaleplon 1 mg
干预措施: Inhaled Zaleplon 1 mg (Drug)
Inhaled Zaleplon 2 mg
Experimental
Staccato Zaleplon 2 mg
干预措施: Inhaled Zaleplon 2 mg (Drug)
Inhaled Zaleplon 4 mg
Experimental
Staccato Zaleplon 4 mg
干预措施: Inhaled Zaleplon 4 mg (Drug)
结局指标
主要结局
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;
时间窗: Single dose
次要结局
- Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses(single dose)
研究者
研究点 (1)
Loading locations...
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