A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

Inclusion Criteria:

• Men and nonpregnant, nonlactating women were 18 years or older.
• Women declaring postmenopausal or surgical sterility.
• Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
• Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).

Exclusion Criteria:

• Institutionalized

• Reported or was known to have done the following:

  • Used any tobacco product.
  • Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
  • Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
  • Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
  • Recently changed dietary or exercise habits significantly
• Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.
• Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• Received an investigational drug within 30 days prior to the initial dose of study medication.
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
• History of drug and/or alcohol abuse within 1 year prior to the study.
• Acute illness at the time of either the pre study medical evaluation or dosing.
• Any laboratory results deemed clinically significant by the physician.
• Abnormal and clinically relevant ECG tracing.
• Donated or lost a significant volume of blood or plasma (>450 mL) within 28 days prior to the initial dose of study medication.
• Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.
• History of seizures or cerebrovascular disease.