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

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02174068

CHU-0191

2014-000624-22

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

paracetamol

Experimental group

Description:

drug interaction between paracetamol and nefopam in healthy volunteers.

Treatment:

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