Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00158093
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00158093
Study Brief:
Protocol Section:
NCT00158093