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

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 Fed Conditions

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Carvedilol

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 Fed Conditions.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Carvedilol; Carvedilol Tablets 25 mg of Dr Reddys Laboratories Limited	Drug: Carvedilol; Carvedilol Tablets 25 mg; Other Names: Coreg Tablets 25 mg
ACTIVE_COMPARATOR: Coreg; Coreg Tablets 25 mg of GlaxoSmithKline	Drug: Carvedilol; Carvedilol Tablets 25 mg; Other Names: Coreg Tablets 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under non-fasting condition	4 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Study Director: Benoit Girard, MD, Anapharm Inc, Canada, H3X 2H9

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (ACTUAL): May 1, 2002
• Study Completion (ACTUAL): May 1, 2002

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 4, 2010
• First Posted (ESTIMATE): February 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2010
• Last Update Submitted That Met QC Criteria: February 4, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: 02118