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

NCT01064154 | Completed Phase 1

• 1 other identifier: 02117
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under fasting condition

  4 months

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol Tablets 25 mg of Dr Reddys Laboratories Limited

Drug: Carvedilol

Coreg

ACTIVE COMPARATOR

Coreg Tablets 25 mg of GlaxoSmithKline

Drug: Carvedilol

Interventions

Carvedilol DRUG

Carvedilol Tablets 25 mg

Also known as: Coreg Tablets 25 mg

Carvedilol; Coreg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Eric Bircell, MD

  Anapharm Inc, Canada, GIV 2K8

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: May 1, 2002
• Primary Completion: May 1, 2002
• Study Completion: May 1, 2002
• Last Updated: February 8, 2010

Record last verified: 2010-02