Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Noncompartmental Pharmacokinetic parameters
研究概览
简要总结
The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.
详细描述
Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Single-center, single-dose, single-treatment, open label study
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
- •Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
- •Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.
排除标准
- •Any acute illness in the 5 days,
- •Use of a bronchodilator for the treatment of wheezing within 12 months, OR
- •Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.
研究组 & 干预措施
Healthy smokers
Healthy smokers, male and female
干预措施: Inhaled Loxapine 10 mg (Drug)
Healthy nonsmokers
Healthy nonsmokers, Healthy smokers, male and female
干预措施: Inhaled Loxapine 10 mg (Drug)
结局指标
主要结局
Noncompartmental Pharmacokinetic parameters
时间窗: 24 hours
次要结局
- Vital signs(24 hours)
- Treatment emergent adverse events(24 hours)
- Sedation visual analog scale(24 hours)