NCT01432522已完成不适用
Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Composite of Pharmacokinetics of epinephrine
研究概览
简要总结
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.
详细描述
Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •18-30 years-old
排除标准
- •Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
研究组 & 干预措施
epinephrine IN, epinephrine IM, saline IN
Experimental
- Intranasal saline
- Intramuscular epinephrine
- Intranasal epinephrine
干预措施: Epinephrine (Drug)
结局指标
主要结局
Composite of Pharmacokinetics of epinephrine
时间窗: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
次要结局
- Numbers of participants with adverse events as a measure of safety and tolerability(1 year)
研究者
Pakit Vichyanond, MD
Professor of Pediatrics
Siriraj Hospital
研究点 (1)
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