A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Healthy Volunteers Clinical Trial

— PARA-NEF  

Official title:

A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174068
• Other study ID #: CHU-0191
• Secondary ID: 2014-000624-22
• Status: Completed
• Phase: Phase 1
• First received: May 26, 2014
• Last updated: July 24, 2014
• Start date: July 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of drug interaction	Drug metabolites and principle assessing by LC / MS / MS in blood samples. Determining of Cmax, Tmax, AUC and Half-life	AT DAY 1	Yes
Secondary	influence of paracetamol on the kinetics of nefopam		AT DAY 1	Yes
Secondary	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	Yes
Secondary	Measure of plasma pharmacokinetic parameters in combination (AUC, Cmax, Tmax, half-life time of apparent elimination terminal).		at day 1	Yes