Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

NCT ID: NCT00834795

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2001-12-31

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

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Carvedilol

Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period

Group Type: EXPERIMENTAL

Carvedilol 25 mg tablets

Intervention Type: DRUG

1 x 25 mg

Coreg®

Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

COREG® 25 mg tablets

Intervention Type: DRUG

1 x 25 mg

Interventions

Carvedilol 25 mg tablets

1 x 25 mg

Intervention Type: DRUG

COREG® 25 mg tablets

1 x 25 mg

Intervention Type: DRUG

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

M David Ayra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

01268

Identifier Type: -

Identifier Source: org_study_id