Status:
COMPLETED
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
Lead Sponsor:
Mylan Bertek Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00158093
Start Date
June 1 2003
End Date
July 1 2003
Last Update
September 12 2005
Active Locations (1)
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1
SFBC International, Inc.
Miami, Florida, United States, 33181