A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI)

Inclusion criteria

• Healthy male or female subjects between 18 and 65 years of age and body mass index (BMI) within the range 18.5 to 29.0 kilogram/meter squared.
• Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN).
• Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
• Average QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 millisecond.
• Forced Expiratory Volume in 1 Second (FEV1) > or = 85% predicted at screening.
• Current non-smokers
• Able to satisfactorily use the NDPI.

Exclusion criteria

• Subjects must not have a systolic blood pressure above 145 milimeter(mm) of mercury(Hg) or a diastolic pressure above 85 mmHg at the screening visit.
• History of breathing problems in adult life confirmed by normal lung function parameters (≥85% predicted).
• Donation of more than 500 mL blood within a 56 day period.
• Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
• The subject treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
• The subject has a positive: drug/alcohol, Hepatitis, HIV screen.
• Abuse of alcohol.
• Subject having positive cotinine and urine alcohol test.
• Participated in >3 clinical trials in the previous 10 months (if male), or >2 clinical trials in the previous 10 months (if female), or the subject has participated in a study (including follow up) within 60 days prior to the first dosing day in the current study.
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Taken systemic, oral or depot corticosteroids less than 12 weeks or inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
• Use of prescription or non-prescription drugs.
• History of severe milk protein allergy, sensitivity to any of the study medications, including immediate or delayed hypersensitivity to any intranasal, inhaled or systemic corticosteroid therapy.
• Pregnant or lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.