Crossover Pharmacokinetic Study of Two Mode of Administration of Intranasal Dexmedetomidine in Healthy Adult Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Bioavailability of dexmedetomidine
研究概览
简要总结
Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®).
Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.
详细描述
This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -
排除标准
- 未提供
研究组 & 干预措施
drip
干预措施: Dexmedetomidine (Drug)
iv
干预措施: Dexmedetomidine (Drug)
atomizer
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Bioavailability of dexmedetomidine
时间窗: 8 hours
次要结局
- sedation score(8 hours)
研究者
YUEN, Vivian Man-ying
Dr
The University of Hong Kong