NCT02184767已完成1 期
A Nonrandomized, Open-Label, Multicenter, Phase 1 Study to Assess the Safety and Pharmacokinetics of ADASUVE® (STACCATO® Loxapine for Inhalation) at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
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
- 30
- 试验地点
- 2
- 主要终点
- area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)
研究概览
简要总结
This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ADASUVE®
Experimental
oral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight
干预措施: ADASUVE® (Drug)
结局指标
主要结局
area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)
时间窗: 48 hours
次要结局
- maximum observed plasma drug concentration (Cmax)(48 hours)
- time to maximum observed concentration (tmax)(48 hours)
- volume of distribution (V/F)(48 hours)
- area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)(48 hours)
- The palatability of ADASUVE will be performed using a visual analog scale (VAS)(2 1/2 weeks)
- ratio of AUC0-t to AUC0-inf (AUC0-t/AUC0-inf)(48 hours)
- apparent terminal elimination rate constant (Kel)(48 hours)
- elimination half-life (t½)(48 hours)
- apparent clearance (CL/F)(48 hours)
- Summary of participants with adverse events(3 weeks)
研究者
研究点 (2)
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