Lamivudine and Adefovir Dipivoxil Fixed Dose Combination

Exclusion Criteria

• •Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstance making the subject unsuitable for participation in the study.
• •Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements, as well as grapefruit-containing products) within 7 days or five half-lives prior to first dose of study medication and until the end of the study. Excluded from this list is acetaminophen at doses of \<=2 grams/day.
• •Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding Day 1 of treatment period 1.
• •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• •History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
• •Positive urine drug screen (UDS) or breath alcohol test at screening. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• •Positive for hepatitis B, hepatitis C or HIV.
• •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •Electrocardiogram findings as follows (a single repeat is allowed for eligibility determination):
• •Parameter Males Heart rate \<45 and \>100 beats per minute PR Interval \<120 and \>220 msec QRS duration \<70 and \>120 msec QTc interval (Bazett) \>450 msec
• •Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization).
• •Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrio-ventricular block \[second degree or higher\], Wolf Parkinson White syndrome).
• •Sinus pauses \>3 seconds.
• •Any significant arrhythmia which, in the opinion of the principal Investigator and GlaxoSmithKline medical monitor, will interfere with the safety for the individual subject.
• •Non-sustained or sustained ventricular tachycardia (\>=3 consecutive ventricular ectopic beats).
• •* Documented history of low blood pressure (BP; average systolic BP\<=90 mmHg and/or diastolic BP \<=45 mm Hg) or blood pressure below these values at time of screening.
• •* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• •* History of asthma or chronic obstructive pulmonary disease.
• •* History of sensitivity to heparin, heparin- induced thrombocytopenia, or sensitivity to any of the study medications or components thereof.
• •* History of anaphylaxis or anaphylactic reactions or severe allergic responses to drugs.
• •* History of angioedema.
• •* Unwillingness or inability to follow the procedures outlined in the protocol or inability to provide written informed consent.
• •* Subject is mentally or legally incapacitated