Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers

Exclusion Criteria

• •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• •Any subject with a systolic blood pressure (BP) \<95mmHg or with a recent history of postural symptoms.
• •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.
• •A positive test for HIV antibody.
• •History of regular alcohol consumption within 6 months of the study defined as:
• •An average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (100 ml) of wine or 1 (25 ml) measure of spirits.
• •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
• •Unable to refrain from the 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 thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• •Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• •Pregnant females as determined by positive urine human chorionic gonadotrophin (hCG) test at Day -1 or serum hCG at all other timepoints.
• •Lactating females.
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Subject is mentally or legally incapacitated.
• •History of sensitivity to heparin or heparin-induced thrombocytopenia.
• •Subjects who have asthma or a history of asthma
• •Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• •Positive carbon monoxide (CO) on admission to the Unit.
• •Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice (and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.