NCT01939444已完成2 期
A Pilot Study of the Bioavailability of Nasal Naloxone
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- preliminary bioavailability of nasal naloxone
研究概览
简要总结
The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:
- Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
- Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
- Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
- Safety of the formulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
- •informed consent
排除标准
- •history of liver disease
- •taking any medications including herbal medicines the last week history of drug abuse
- •any local nasal disease or nasal surgery or recent cold for the last week
- •any history of drug allergies
研究组 & 干预措施
naloxone intranasal
Experimental
2.0 mg by the nasal route
干预措施: naloxone intranasal (Drug)
naloxone intravenous
Active Comparator
1.0 mg intravenous
干预措施: naloxone intravenous (Drug)
结局指标
主要结局
preliminary bioavailability of nasal naloxone
时间窗: 2 weeks
measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.
次要结局
- time to maximum concentrations(2 weeks)
- maximum concentration(2 weeks)
研究者
研究点 (1)
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