Pharmacokinetic study of the use of Nefopam 30 mg tablet in patients suffering from acute pain in rheumatology - NEFOPAIN kinetics

Condition studied

Hospitalized patient with acute rheumatological pain, requiring nefopam if necessary

Investigational medicinal product(s)

Eligibility

Primary endpoint

main PK parameters will be determined using PKAnalix 2024R1 software (MonolixSuite, Saclay, France). They will include terminal elimination half-life, maximum concentration (Cmax), time at maximum concentration (Tmax) and exposure, characterized by the area under the curve obtained using the trapezoidal method. Bbioavailability will be calculated as the ratio of the AUC between the oral and intravenous forms, normalized to the dose for each patient using the cross-over design

Endpoint detail

volume of distribution (Vd), maximum plasma concentration of the PO form (Cmax), time after intake for which the concentration is maximum (Tmax), terminal elimination half-life and bioavailability, and to highlight potential clinico-biological factors responsible for a variation in exposure. The flexibility of the modeling will then enable different doses to be simulated to determine the optimal dosages maximizing likelihood with the IV route.