Clareo Health | A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mylan Bertek Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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).
You may not be if
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.
