Bioequivalence of generic and branded fluticasone propionate nasal spray

Abstract

Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase , and Flixonase in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the area under the plasma concentration-time curve (AUC 0-t ). Secondary parameters included the maximum plasma concentration (C max ). FANS was compared to Flonase and to Flixonase separately. Results: Bioequivalence between FANS and Flonase (n=55) was demonstrated by the inverse log transformed AUC 0-t (ratio FANS to Flonase = 1.021; 90%CI, 0.88 to 1.19), and C max , (ratio = 0.995; 90% CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase (n=54) was also demonstrated for AUC 0-t (ratio = 0.949; 90%CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90% CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase and Flixonase when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase and Flixonase.