Overview

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 (COREGĀ®, 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.