Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01064154
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting Conditions


Condition Intervention Phase
Healthy
Drug: Carvedilol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized,2-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under fasting condition [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2002
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carvedilol
Carvedilol Tablets 25 mg of Dr Reddys Laboratories Limited
Drug: Carvedilol
Carvedilol Tablets 25 mg
Other Name: Coreg Tablets 25 mg
Active Comparator: Coreg
Coreg Tablets 25 mg of GlaxoSmithKline
Drug: Carvedilol
Carvedilol Tablets 25 mg
Other Name: Coreg Tablets 25 mg

Detailed Description:

A Randomized,two-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions.

Treatment Duration: Single dose of the two treatments (A, B) in two different occasions, separated by a washout period of 7 days.

  Eligibility

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

Inclusion Criteria:

Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Website, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:

  • Subjects will be females and/or males, smokers and non-smokers, 18 years of age & older.
  • Female subjects will be post-menopausal/surgically sterilized.

    • Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
    • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

  • Clinically significant illnesses/surgery within 4 weeks prior to the administration of study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Subjects with a clinically significant history of second- or third-degree AV block, sick sinus syndrome or severe bradycardia or in patients with cardiogenic shock who have decompensated heart failure.
  • Subjects with history of hepatic failure.
  • Presence or history of liver disease, cardiovascular disease, diabetes, hyperthyroidism aDd peripheral vascular disease.
  • Positive urine drug screen or positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure <ll0 or over 140 mmHg, or diastolic blood pressure <70 or over 90 mmHg; or heart rate <60 or over 100 bpm) at screening.
  • Subjects with BMI ≥30.0.
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
  • History of allergic reactions to carvedilol or other beta-blocking agents (e.g. propranolol, labetalol, acebutolol, atenolol, esmolol, metoprolol, oxprenolol, timolol, pindolol, betaxolol, levobunolol and nadolol).
  • History of pulmonary or bronchospastic disease (including asthma).
  • Subjects with pheochromocytoma.
  • History of allergic reactions to heparin.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
  • less than 300 mL of whole blood within 30 days or
  • 300 mL to 500 mL of whole blood within 45 days or
  • more than 500 mL of whole blood within 56 days.
  • Smoking more than 25 cigarettes per day.
  • Subjects who have consumed food or beverages containing grapefruit (e.g. fresh, canned,or frozen) within 7 days prior to administration of the study medication.

Additional exclusion criteria for females only:

• Breast-feeding subjects.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064154

Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Eric Bircell, MD Anapharm Inc, Canada, GIV 2K8
  More Information

No publications provided

Responsible Party: Assistanct Manager - Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01064154     History of Changes
Other Study ID Numbers: 02117
Study First Received: February 4, 2010
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

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 17, 2014