Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Bioavailability (%) of subcutaneously given dexmedetomidine
研究概览
简要总结
The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously 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
- Treatment
- 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 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.
- •Body weight < 60 kg or 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
研究组 & 干预措施
intravenous
1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) diluted in 10 ml of sodium chloride will be administered intravenously in 10 min at a constant rate using an infusion pump.
干预措施: Dexmedetomidine (Drug)
subcutaneous
1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Bioavailability (%) of subcutaneously given dexmedetomidine
时间窗: 10 hours
Noncompartmental analysis after non-linear mixed effects modelling.
次要结局
- Change in hemodynamic parameter (heart rate)(10 hours)
- Number of participants with adverse events as a measure of safety and tolerability(7 days)
- Change in hemodynamic parameter (blood pressure)(10 hours)