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.
Completed
- Conditions
- chronic inflammation of the bronchial tubesshortness of breath10024970
- Registration Number
- NL-OMON37181
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Healthy male or female
Between 18 and 65 years of age inclusive
BMI within the range 18.5-29.0 kg/m2 (inclusive).
Exclusion Criteria
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics: plasma drug concentrations<br /><br>Safety: adverse events, physical examination if medically indicated</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>