Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The absolute bioavailability of intranasally administered dexmedetomidine
研究概览
简要总结
In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration.
The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
- •Age ≥ 18 years.
- •Male gender.
- •Weight ≥ 60 kg.
- •Written informed consent from the subject.
排除标准
- •Previous history of intolerance to the study drug or related compounds and additives.
- •Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
- •Existing or recent significant disease.
- •History of hematological, endocrine, metabolic or gastrointestinal disease.
- •History of asthma or any kind of drug allergy.
- •Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- •Donation of blood within six weeks prior to and during the study.
- •Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
- •BMI > 30 kg / m
- •Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- •Smoking during one month before the start of the study or during the study period.
- •Clinically significant abnormal findings in physical examination, ECG or laboratory screening [routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)].
研究组 & 干预措施
Intravenous dexmedetomidine
Dexmedetomidine is administered intravenously
干预措施: Intravenous dexmedetomidine (Drug)
Intranasal administration
Dexmedetomidine is administered intranasally
干预措施: Intranasal dexmedetomidine (Drug)
结局指标
主要结局
The absolute bioavailability of intranasally administered dexmedetomidine
时间窗: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.
次要结局
- The effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation, local and systemic safety and tolerability of intranasal dexmedetomidine.(At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 5 and 10 h. Only local nasal tolerability is assessed at 5 and 10 h.)