Asthma Clinical Trial
Official title:
An Open Label, Part-randomised, Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate (FF) When Administered as FF Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects
The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram
(mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI
containing FF formulated with lactose. In addition, the aim of this study is to determine
the absolute bioavailability of the FF single strip product using the high strength product
administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV)
FF.
This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult
subjects. During each period, subjects will receive FF in the morning and serial
pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days
for the IV treatment) and safety assessments will be performed. Each period will be
separated by a washout period of at least 7 days and a follow-up telephone call will occur 7
-14 days after the last dose of study drug. The total duration of the study will be
approximately 13-14 weeks for each subject.
n/a
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