Healthy Volunteers
Conditions
Keywords
Paracetamol, Nefopam, Pharmacokinetic, Drug interaction
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.
Detailed description
This is a randomised, cross-over, open label trial assessing drug interaction between paracetamol and nefopam in healthy volunteers.
Interventions
DRUGparacetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed