Status:
COMPLETED
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- Sex: Male of Female; similar proportions of each preferred.
- Age: At least 18 years.
- Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.
Exclusion
- Subjects not complying with the above inclusion criteria must be excluded from the study.
- In addition, any one of the conditions listed below will exclude a subject from the study.
- History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
- History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
- History of treatment for any gastrointestinal disorder within the past five (5) years.
- History of, or presence of, asthma
- History of peripheral vascular disease
- History of heart failure
- History of pre-existing cardiac arrythmias associated with tachycardia
- History of severe sensitivity to allergens, requiring urgent medical treatment.
- Females who are pregnant or lactating
- History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.
- Conditions upon screening which might contraindicate or require that caution be used in the administration of carvedilol, including:
- sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.
- Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.
- Inability to read and/or sign the consent form.
- Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
- Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums,etc.) Ninety (90) days abstinence is required.
- subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00834795
Start Date
December 1 2001
End Date
December 1 2001
Last Update
August 19 2024
Active Locations (1)
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1
Gateway Medical Research, Inc.
Saint Charles, Missouri, United States, 63301