Hospitalized patient with acute rheumatological pain, requiring nefopam if necessary
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGsolution injectable
DRUGNefopam Panpharma 30 mg
DRUGcomprimé pelliculé
Sponsors
Centre Hospitalier Universitaire Rouen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Outcome results
None listed