Bioequivalence study of fluticasone propionate nebuliser suspensions in healthy Chinese subjects.

Background: Fluticasone propionate is a synthetic trifluoro-substituted glucocorticoid, a highly selective glucocorticoid receptor agonist. Fluticasone propionate nebuliser suspensions is an inhaled corticosteroid with the low systemic bioavailability which provides a low risk (benefit outcome without the adverse effects that accompany systemically administered corticosteroids), referred as a first-line preventive agent for patients with persistent asthma. China has become one of the countries with the highest asthma mortality rate in the world in the past years. It urgently needs good generic drugs to help ease patients' burden and improve their quality of life. Objective: The primary objective of this study was to evaluate the bioequivalence of fluticasone propionate nebuliser suspensions between test formulation (generic product) and reference formulation (original product, Flixotide Nebules Methods: The bioequivalence study was conducted with a single-center, randomized, open-label, single-dose, two sequences, two-period crossover design. 24 healthy subjects were randomly assigned into T-R and R-T sequence groups with 12 patients in each group. The subjects were administered 1 mg (2 mL:0.5 mg,plastic ampoules) of generic fluticasone propionate nebuliser suspension as a test formulation or Flixotide Nebules Results: The 90% confidence intervals of the T/R ratio of the geometric mean of C Conclusion: The test and reference formulations of fluticasone propionate nebuliser suspension were pharmacokinetic bioequivalent and were well tolerated and safe in all subjects.