A study to compare COREG CR to COREG CR fixed-dose combination in patients with high blood pressure

Body weight > 60 kg (132 pounds) and body mass index (BMI) between 19 and 35 Exclusion criteria:

• Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstances making the volunteer unsuitable for participation in the study.
• History of advanced retinopathy (i.e., Keith-Wagener Grade III or IV)
• Secondary forms of hypertension including (but not limited to) coarctation of the aorta, primary aldosteronism, renal artery stenosis, or pheochromocytoma
• Type 1 diabetics [note: Type 2 diabetics with HgbA1c less than or equal to 9.0% can be enrolled provided the Investigator considers the subject clinically stable]
• Signs, symptoms, or history of congestive heart failure, angina pectoris, myocardial infarction, cerebrovascular accident, or transient ischemic attacks
• History or presence of clinically significant hepatic disease
• Liver function tests (ALT, AST, total bilirubin or alkaline phosphatase) more than 2 times the upper limit of the laboratory reference range
• History of severe pulmonary disease including asthma or chronic obstructive lung disease or previous history of 'hypersensitivity' to B-blockers
• Previously treated hypertension in subjects in whom, at the discretion of the Investigator, antihypertensive therapy cannot be safely withdrawn during the study
• Subjects who are on more than 3 antihypertensive or diuretic medications [Note: combination antihypertensive and/or diuretic products (such as lisinopril and hydrochlorothiazide) should be considered as 2 medications, and the doses of each component should be recorded.]
• Subjects who metabolize carvedilol poorly based on CYP2D6 genotyping as determined at screening
• 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) including alcohol at screening. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• Treatment with an investigational drug within 30 days or five half-lives, whichever is longer, prior to the first dose of study medication (this includes investigational formulations of marketed products)
• Subjects receiving ongoing treatment or anticipated to receive treatment with any of the following medications during treatment with study medication: