Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: All

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 dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 36 adult individuals under fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.