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NCT Number: NCT02174068

A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os

Drug

Primary outcomes

  1. Existence of drug interaction

    Time frame: AT DAY 1

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

Secondary outcomes

  1. influence of paracetamol on the kinetics of nefopam

    Time frame: AT DAY 1

  2. Measure of plasma pharmacokinetic parameters of each active metabolites and principles (dosage nefopam, N-desmethyl-nefopam, paracetamol, paracetamol glucuronide, paracetamol sulfate) alone

    Time frame: at day 1

  3. Measure of plasma pharmacokinetic parameters in combination (AUC, Cmax, Tmax, half-life time of apparent elimination terminal).

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PARA-NEF

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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