Pharmacokinetic Study of Levocetirizine Oral Solution

Exclusion Criteria

• •The subject is positive for syphilis, Hepatitis B surface antigen, Hepatitis C antibody, HIV1/2 antibody, or HTLV-1 antibody at screening.
• •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •The subject has a history of allergic rhinitis.
• •The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
• •The subject has a history or current conditions of drug abuse or alcoholism.
• •A positive pre-study drug screen.
• •History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>14 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (350 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
• •The subject has participated in a clinical trial and has received an investigational product or a non-investigational drug within 4 months 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.
• •Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days 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 thereof or a history of drug or other allergy.
• •Where participation in the study would result in donation of blood or blood products =\> 400 mL within 3 months or =\> 200 mL within 1 month.
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Subject is mentally or legally incapacitated.