NCT01889290已完成1 期
Pharmacokinetics of Once Daily Subcutaneous Methylnaltrexone in Neurointensive Care Patients With High Dose Sufentanil Analgosedation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
研究概览
简要总结
- Assessment of pharmacokinetic parameters of once daily subcutaneously administered methylnaltrexone in 10 evaluable neurointensive care patients.
- Quantification of methylnaltrexone passage through the blood-brain-barrier in critically ill patients with severe cerebral affections.
- Observation of laxation response after methylnaltrexone application and relation to plasma concentrations of methylnaltrexone.
- Assessing the safety of once daily administered methylnaltrexone in neurointensive care patients.
- Trial with medicinal product
详细描述
After administration of methylnaltrexone s.c. multiple peripheral blood samples and additionally two liquor samples are drawn during a dose interval on day 1, 3, and 5 of drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Methylnaltrexone
Experimental
Pharmacokinetics of methylnaltrexone administered once daily
干预措施: Methylnaltrexone (Drug)
结局指标
主要结局
Pharmacokinetic parameters of methylnaltrexone (Cmax, tmax, area under the curve, total clearance, halflife, accumulation ratio, renal clearance)
时间窗: 5 days
次要结局
未报告次要终点
研究者
研究点 (1)
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