OBJECTIVE:

To evaluate the effects of different dosing intervals on multiple-dose pharmacokinetics, and safety and tolerability of fentanyl pectin nasal spray (FPNS).

METHODS:

This was an open-label study in healthy volunteers. Five FPNS treatments (1×100 μg; 2×100 μg at 4-, 2-, and 1-hour intervals, and 8×100 μg consecutively) were administered to the right nostril, with a ≥3-day washout period. Blood samples were collected at predose and up to 1,440 minutes postdose. Plasma fentanyl concentrations were determined. Pharmacokinetic parameters-peak concentration (Cmax), time to Cmax (tmax), and area under the concentration-time curve (AUC)-were derived using noncompartmental method. For the two-dose regimens, pharmacokinetic parameters were compared between doses using a paired t-test with p <0.05 as statistically significant.

 

(후략)