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临床试验/NCT02174068
NCT02174068已完成1 期

A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Existence of drug interaction

研究概览

简要总结

Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a significant percentage of patients disclaim little or no pain relief with common analgesics, specific or not their type of pain. This is especially true in cases of chronic pain, and current treatments are associated with many side effects. A need for therapeutic innovation is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its excellent safety, its analgesic effect is limited from moderate to severe pain. Many analgesic drug combinations include paracetamol, recently the co-administration of paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et al. 2013). The development of a formulation associating paracetamol and nefopam first requires searching a possible pharmacokinetic interaction between the two active substances and assessing safety of this combination in healthy volunteers. No published studies providing such information.

详细描述

This is a randomised, cross-over, open label trial assessing drug interaction between paracetamol and nefopam in healthy volunteers.

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

入选标准

  • Age over 18
  • ALT, AST, PAL, normal GGT, creatinine <133μmol / L, hematocrit>38%
  • Informed consent to the trial
  • Healthy volunteers affiliated to the French Social Security

排除标准

  • 未提供

研究组 & 干预措施

paracetamol

Experimental

drug interaction between paracetamol and nefopam in healthy volunteers.

干预措施: paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os (Drug)

结局指标

主要结局

Existence of drug interaction

时间窗: AT DAY 1

Drug metabolites and principle assessing by LC / MS / MS in blood samples. Determining of Cmax, Tmax, AUC and Half-life

次要结局

  • Measure of plasma pharmacokinetic parameters of each active metabolites and principles (dosage nefopam, N-desmethyl-nefopam, paracetamol, paracetamol glucuronide, paracetamol sulfate) alone(at day 1)
  • influence of paracetamol on the kinetics of nefopam(AT DAY 1)
  • Measure of plasma pharmacokinetic parameters in combination (AUC, Cmax, Tmax, half-life time of apparent elimination terminal).(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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