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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014