PARA-NEF: A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT02174068

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: paracetamol drug interaction between paracetamol and nefopam in healthy volunteers.	Drug: paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os

Arm

Intervention/Treatment

Experimental: paracetamol

drug interaction between paracetamol and nefopam in healthy volunteers.

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

Outcome Measures

Primary Outcome Measures

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

influence of paracetamol on the kinetics of nefopam [AT DAY 1]
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]
Measure of plasma pharmacokinetic parameters in combination (AUC, Cmax, Tmax, half-life time of apparent elimination terminal). [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Claude DUBRAY, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT02174068

Other Study ID Numbers:

CHU-0191
2014-000624-22

First Posted:

Jun 25, 2014

Last Update Posted:

Jul 25, 2014

Last Verified:

Jul 1, 2014

Keywords provided by University Hospital, Clermont-Ferrand

Additional relevant MeSH terms:

Acetaminophen

Nefopam

Study Results

No Results Posted as of Jul 25, 2014