Bioequivalence Study of 2 Formulations of Fluticasone Nasal Spray in Healthy Chinese Volunteers.

Abstract

This study aimed to evaluate the pharmacokinetic characteristics, safety, and bioequivalence of 2 formulations of fluticasone nasal spray in healthy Chinese subjects. A single-center, randomized, open-label, single-dose, 2-formulation, 2-sequence, 2-period crossover bioequivalence study was conducted under fasting conditions. A total of 120 healthy male and female subjects were enrolled, of which 119 subjects completed the entire study. The main pharmacokinetic parameters of the parent drug, fluticasone propionate (FP), in plasma were as follows: For the test formulation, maximum plasma concentration (C_max) was 10.3 pg/mL, area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC_0-t) was 65.6 pg•h/mL, and area under the plasma concentration-time curve from time zero to infinity (AUC_0-∞) was 86.4 pg•h/mL. For the reference formulation: C_max was 8.80 pg/mL, AUC_0-t was 58.2 pg•h/mL, and AUC_0-∞ was 75.2 pg•h/mL. The 90% confidence intervals of the geometric means for AUC_0-t, AUC_0-∞, and C_max between the 2 formulations were 105%-120%, 103%-120%, and 112%-124%, respectively. The results show that the test and reference formulations were well tolerated, with no serious adverse events reported. According to the criteria for bioequivalence, the FP nasal spray (test formulation) is bioequivalent to the reference formulation.