Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Identification of the pharmacokinetic parameters: AUC
研究概览
简要总结
The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.
详细描述
The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:
- The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
- The association between the PK parameters and pathophysiological factors
- The correlation between PK parameters and clinical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a minimum age of 80 years
- •admission to the acute geriatrics ward
- •oral intake of paracetamol 1000 milligram (mg) in tablet form tid
- •a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)
排除标准
- •palliative care setting with downgrading of care
结局指标
主要结局
Identification of the pharmacokinetic parameters: AUC
时间窗: 8 hours (= during 1 dosing interval at steady state)
Area under the curve (AUC)
Identification of the pharmacokinetic parameters: Cmax
时间窗: 8 hours (= during 1 dosing interval at steady state)
Peak plasma concentration after administration of paracetamol (Cmax)
Identification of the pharmacokinetic parameters: Tmax
时间窗: 8 hours (= during 1 dosing interval at steady state)
The time at which the Cmax is observed (Tmax) of paracetamol
次要结局
- Variability in plasma exposure: t1/2(8 hours (= during 1 dosing interval at steady state))
- Variability in plasma exposure: Vd(8 hours (= during 1 dosing interval at steady state))
- The association between the AUC (area under the curve) of paracetamol and patient related factors.(8 hours (= during 1 dosing interval at steady state))
- Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum(8 hours (= during 1 dosing interval at steady state))
- Variability in plasma exposure: Cl(8 hours (= during 1 dosing interval at steady state))
- The association between the AUC (area under the curve) of paracetamol and pain scores.(8 hours (= during 1 dosing interval at steady state))
研究者
Isabelle Spriet
PharmD, PhD
Universitaire Ziekenhuizen KU Leuven