Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects

A Randomized, Two-Way Crossover, Single-Dose, Open Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Carvedilol (25 mg), Compared to an Equivalent Dose of COREG® (SmithKline Beecham Pharmaceuticals) in 24 Fed, Healthy, Adult Subjects

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 24 adult individuals under fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Carvedilol 25 mg tablets; Drug: COREG® 25 mg tablets

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Gateway Medical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carvedilol; Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period	Drug: Carvedilol 25 mg tablets; 1 x 25 mg
Active Comparator: Coreg®; Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period	Drug: COREG® 25 mg tablets; 1 x 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration - Carvedilol in Plasma	Bioequivalence based on Cmax	Blood samples collected over 60 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma	Bioequivalence based on AUC0-inf	Blood samples collected over 60 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma	Bioequivalence based on AUC0-t	Blood samples collected over 60 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: M David Ayra, M.D., Gateway

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): December 1, 2001
• Study Completion (Actual): December 1, 2001

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 11, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: 01269