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Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

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ClinicalTrials.gov Identifier: NCT00834795
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 18, 2009
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Carvedilol 25 mg tablets Drug: COREG® 25 mg tablets Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2001
Primary Completion Date : December 2001
Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Cmax - Maximum Observed Concentration - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00834795     History of Changes
Other Study ID Numbers: 01268
First Posted: February 3, 2009    Key Record Dates
Results First Posted: August 18, 2009
Last Update Posted: September 15, 2009
Last Verified: September 2009

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
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists