Pharmacokinetics and Bioequivalence of 2 Products of Fluticasone Propionate Nasal Spray in Healthy Chinese Subjects.

Abstract

Fluticasone propionate nasal spray is widely regarded as a first-line therapy for allergic rhinitis. To establish bioequivalence between the test and reference products of fluticasone propionate nasal spray, an open-label, randomized, single-dose, and 2-sequence crossover study was conducted on 84 healthy Chinese subjects under fasting conditions to determine the pharmacokinetic bioequivalence of the 2 products. Following a single-dose administration (200 µg) of fluticasone propionate nasal spray, pharmacokinetic parameters, including maximum plasma concentration, area under the concentration-time curve from administration to the last measurable concentration, and area under the concentration-time curve from administration to infinity, exhibited similarity between the 2 products, with 90% confidence intervals for the test/reference ratios falling within the bioequivalence range of 80%-125%.