A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864435
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Carvedilol 12.5 mg Tablets, single dose
Drug: Coreg® 12.5 mg Tablets , single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Two-Way Crossover, Open-Label, Single Dose, Fasting, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Carvedilol 12.5 mg Tablets, single dose
Drug: Carvedilol 12.5 mg Tablets, single dose
A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fasting conditions
Active Comparator: B
Coreg® 12.5 mg Tablets , single dose
Drug: Coreg® 12.5 mg Tablets , single dose
B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fasting conditions
Other Name: Carvedilol

Detailed Description:

Study Type: Interventional Study Design: Two-way crossover, randomized, open-label, single-dose, fasting, bioequivalence study

Official Title: A Two-Way Crossover, Open-Label, Single Dose, Fasting, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-smoking male or female with a minimum age of 18 years.
  2. Body Mass Index (BMI = weight/heigh2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
  3. Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 106-140/66-90 mmHg, heart rate between 60-99 beats/minute, temperature between 35.8°C and 37.5°C)
  4. Negative for drugs of abuse and nicotine.
  5. Negative for hepatitis B-surface antigen, hepatitis C and HIV.
  6. Female subjects: negative for pregnancy (as evaluated by serum ß-CG test).
  7. No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides that they are not clinically significant.
  8. Female subjects who were surgically sterile for at least 6 months or post-menopausal for at least 1 year, or avoided pregnancy for at least 10 days before the study, during the study and up until 1 month after the end of the study.
  9. Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF

Exclusion Criteria:

  1. Known history of hypersensitivity to carvedilol (e.g. Coreg®) and/or related beta¬blockers such as propranolol (Inderal®, nadolol (Corgard®), labetalol (Trandate®, metoprolol (Lopressor®, Betaloc®, atenolol (Tenormin®, sotalol, timolol, pindolol, or acebutolol.
  2. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
  3. Presence of any significant physical or organ abnormality.
  4. Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
  5. Known history of frequent headaches or migraines.
  6. Known history of chronic bronchitis or any bronchospastic condition.
  7. Any clinically significant illness during the 4 weeks before this study.
  8. Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  9. Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
  10. Significant or recent history of asthma (after 12 years of age).
  11. Any subject with a history of drug abuse.
  12. Any subject with a recent (less than 1 year) history of alcohol abuse.
  13. Use of any prescription medication within 14 days preceding this study.
  14. Use of any over-the-counter (OTC) cough and cold medication containing dextromethorphan within 14 days preceding this study.
  15. Use of OTC medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
  16. Female subjects: use of contraceptives (oral, emergency [plan B®, transdermal, implant, Mirena® IUD, NuvaRing®) within 30 days before drug administration or a depot injection of progestogen drug (e.g. Depo-Provera® within 1 year before drug administration.
  17. Female subjects: evidence of pregnancy or lactation.
  18. Any subject who had blood drawn within 56 days preceding this study, during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
  19. Participated in a clinical trial with an investigational drug within 30 days preceding this study.
  20. Any subject who had donated blood within 56 days preceding this study.
  21. Any subject who had participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
  22. Intolerance to venipuncture.
  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: NCT00864435

Locations
Canada, Ontario
Biovail Contract Research (A Division of Biovail Corporation)
Toronto, Ontario, Canada, M1L 4S4 / M1L 4R6
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Paul Y. Tam,, MD Biovail Contract Research
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864435     History of Changes
Other Study ID Numbers: 3159
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Carvedilol
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 31, 2014