Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834795
First received: January 30, 2009
Last updated: September 11, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Carvedilol 25 mg tablets
Drug: COREG® 25 mg tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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 36 Fasted, Healthy, Adult Subjects

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834795

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: M David Ayra, M.D. Cetero Research, San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834795     History of Changes
Other Study ID Numbers: 01268
Study First Received: January 30, 2009
Results First Received: May 8, 2009
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on April 23, 2014