Relovair PD PK in Chinese Healthy Subjects

Exclusion Criteria

• •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •A positive pre-study drug/alcohol screen or on admission to the Unit.
• •A positive urinary cotinine test at screening or on admission to the Unit.
• •A positive test for HIV antibody.
• •History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a 285mL glass of full strength beer or 425mL schooner of light beer or 1 (30mL) measure of spirits or 1 glass (100mL) of wine (NHMRC Guidelines \[NHMRC, 2001\]).
• •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• •History of sensitivity to any of the study medications, or components (magnesium stearate and lactose etc.) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• •History of milk protein allergy.
• •History of any adverse reaction including immediate or delayed hypersensitivity to any ICS, β2-agonist or sympathomimetic drug.
• •Blood donation or sampled as a study subject within three months preceding the first dose of study drug and blood donation during the entire study.
• •Pregnant females as determined by positive urine pregnancy test at screening or prior to dosing.
• •Lactating females.
• •Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
• •The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
• •The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Subject is mentally or legally incapacitated.