drugset / Trial / NCT02174068

A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

NCT02174068

Phase 1 Completed 12 enrolled University Hospital, Clermont-Ferrand
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-07
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Oral
Subject Nefopam Small molecule 60 mg Oral

Indications

No indication recorded.