Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Time to Peak (Tmax)
研究概览
简要总结
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
详细描述
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young 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)
盲法说明
Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial
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
- •Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
排除标准
- •Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, 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 prochlorperazine 0.625 mg vs IV
Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg
干预措施: Prochlorperazine 0.5 mg IV over 5 sec (Drug)
Inhaled prochlorperazine 0.625 mg vs IV
Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg
干预措施: Inhaled prochlorperazine 0.625 mg (Drug)
Inhaled prochlorperazine 0.625 mg vs IV
Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg
干预措施: Prochlorperazine 10 mg IV over 5 sec (Drug)
Inhaled prochlorperazine 2.5 mg
Inhaled Staccato prochlorperazine 2.5 mg
干预措施: Inhaled prochlorperazine 2.5 mg (Drug)
Inhaled prochlorperazine 10 mg
Inhaled Staccato prochlorperazine 10 mg
干预措施: Inhaled prochlorperazine 10 mg (Drug)
Inhaled prochlorperazine 1.25 mg
Inhaled Staccato prochlorperazine 1.25 mg
干预措施: Inhaled prochlorperazine 1.25 mg (Drug)
Inhaled prochlorperazine 5 mg
Inhaled Staccato prochlorperazine 5 mg
干预措施: Inhaled prochlorperazine 5 mg (Drug)
inhaled Placebo
inhaled Staccato Placebo (0 mg)
干预措施: Inhaled placebo (Drug)
结局指标
主要结局
Time to Peak (Tmax)
时间窗: 24 hours
Time from dose to peak prochlorperazine concentration
次要结局
- Absolute Bioavailability of Inhaled Prochlorperazine(24 hours)
- Dose Proportionality of Inhaled Prochlorperazine by Power Analysis(24 hours)