Research Article
The Pharmacokinetics of Fluticasone Furoate and Vilanterol Following
Single Inhaled Administration in Combination and Intravenous
Administration of Individual Components in Healthy Subjects
Author(s): Ann Allen, Ludovic Apoux, Jo Bal, Joseph Bianco, Alison Moore, Ramiya Ravindranath, Lee Tombs and Rodger D KempsfordAnn Allen, Ludovic Apoux, Jo Bal, Joseph Bianco, Alison Moore, Ramiya Ravindranath, Lee Tombs and Rodger D Kempsford
Fluticasone furoate (FF)/vilanterol (VI), a novel inhaled corticosteroid/long-acting β 2 -agonist combination, is being developed as a once-daily inhaled treatment for asthma and chronic obstructive pulmonary disease. The two studies described here assess FF dose proportionality and VI equivalence across the clinical strengths of FF/ VI and the absolute bioavailability of the components administered as FF/VI in combination via the dry powder inhaler (DPI) intended for commercial use. Study 1 (NCT01213849) was a randomized, open-label, three-way crossover, single- dose study in healthy subjects designed to assess whether the systemic exposure of FF increased proportionately and VI systemic exposure was constant across different strength combinations of FF/VI (four inhalations of FF/ VI; 50/25 μg, 100/25 μg and 200/25 μg). Study 2 (NCT01299558) was an open-label, non-rando.. View More»
DOI:
10.4172/jbb.10000153