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Purpose It has been previously shown that the complete pharmacokineticprofile, in particular the elimination phase, of intranasal fluticasone furoatehas not been fully characterized due to the inability to quantify concentrationsat low enough levels. This study was designed to evaluate the pharmacokineticprofile of intranasal FF using a validated, ultra-sensitive analytical method inhealthy subjects.  Methods This was an open-label, single-dose, two-period, one-treatment,crossover study. A dose of 880 µg fluticasone furoate wasadministered intra nasally. Blood samples for pharmacokinetic analysis werecollected at 23 time points up to 36 h and analyzed for FF plasma levelsusing a lower limit of quantitation (LLOQ) of 0.1 pg/mL. Medicaland adverse events (AE) were monitored throughout the study.  Results Eighteen subjects were enrolled in and 17 completed the study.The results showed that all 17 subjects had measurable fluticasone furoateplasma concentrations at all time points with a clearly defined eliminationphase, thus allowing estimation of AUCinf andt1/2. Median Tmax was 1.33 h(range=0.75–6.00), mean Cmax was13.05±7.59 pg/mL, mean AUCt was148.48±77.76 pg/mL*h, mean AUCinf was279.07±187.81 pg/mL*h, and meant1/2 was 31.67±29.23 h. In total 4subjects (22.2%) experienced 4 AEs.  Conclusion Using a lower LLOQ than what has been previously reported, acomplete characterization of intranasal fluticasone furoate pharmacokinetics,including a clearly defined terminal elimination phase, was achieved. Thismethod will allow for further investigations into the pharmacokinetics offluticasone furoate.

The Pharmacokinetics of Fluticasone Furoate Given Intranasally in Healthy Subjects Using an Ultra-Sensitive Analytical Assay