A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os

• Registration Number: NCT02174068
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Status Verified: 2014-07
• Study Start: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paracetamol	paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os	drug interaction between paracetamol and nefopam in healthy volunteers.

Primary Outcome Measures

Name	Time	Method
Existence of drug interaction	AT DAY 1	Drug metabolites and principle assessing by LC / MS / MS in blood samples. Determining of Cmax, Tmax, AUC and Half-life

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France