A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

Exclusion Criteria

• •Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used
• •Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)
• •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
• •Any prior clinically significant psychiatric history including hospitalization for mental health management
• •Subject is at risk of urinary retention based on medical history
• •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests
• •Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate \<50 or \>90 bpm; mean systolic blood pressure \<90 mm Hg or \>140 mmHg (\>160 mmHg for subjects 65 years or older); mean diastolic blood pressure \<60 mm Hg or \>90 mmHg (\>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)
• •A QTc interval of \> 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
• •A hemoglobin value \<12.5 g/dl (7.8 mmol/l) and/or a hematocrit value \<37.9% and/or a Red Blood Cell count \<4.08 T/l (4080 mm3)