Research Article
Bioequivalence and Dose Proportionality of Inhaled Fluticasone Furoate
Author(s): Ann Allen, Jo Bal, Alison Moore, Sally Stone and Lee TombsAnn Allen, Jo Bal, Alison Moore, Sally Stone and Lee Tombs
Fluticasone furoate (FF), a new inhaled corticosteroid delivered via the ELLIPTA dry powder inhaler, is being developed as a once-daily inhaled treatment for asthma. Study 1 was a part-randomised, open-label, four-way crossover, single- and repeat-dose study in healthy subjects (n=36) to assess whether the systemic exposure of FF increased proportionately across different strengths of FF (50 μg, 100 μg and 200 μg) and to determine the absolute bioavailability of FF inhalation powder. Study 2 was a randomised, open-label, replicate, six-way crossover, single-dose study in healthy subjects (n=30) to determine the bioequivalence of FF inhalation powder (single-strip configuration) compared with FF inhalation powder (two-strip configuration) and with fluticasone furoate/vilanterol (FF/VI) inhalation powder. A population pharmacokinetic analysis was also conducted on sparse .. View More»
DOI:
10.4172/jbb.1000176