A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

NCT02174068 | Completed Phase 1

• 2 other identifiers: CHU-01912014-000624-22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Paracetamol; Nefopam; Pharmacokinetic; Drug interaction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

paracetamol

EXPERIMENTAL

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

Interventions

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

paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Acetaminophen; Nefopam

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claude DUBRAY

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

FR (1)