Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions

October 17, 2008 updated by: Ranbaxy Laboratories Limited

An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Carvedilol Formulations Comparing Carvedilol 12.5 mg Tablets of Ranbaxy Laboratories With Coreg® 12.5 mg Tablets of Glaxosmithkline in Healthy, Adult, Human Subjects Under Fasting Conditions

The objective of this study was to compare the single-dose oral bioavailability of Carvedilol 12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human subjects under fasting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc, USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in healthy, adult, male, human subjects under fasting condition.

Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as described in the protocol were enrolled in the study. Thirty-six subjects completed both the periods of the study

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be in the' age range of 18-45 years.
  • Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of lndia height/weight chart for non-medical cases.
  • Have voluntarily given written informed consent to participate in this study.
  • Be of normal health as determined by medical history and physical examination of the subjects performed within :1.4 days prior to the commencement of the study.

If female and:

  • Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device ([UD), or abstinence; or Is postmenopausal for at least 1 year; or
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  • History of allergy to 13-adrenoceptor antagonists especially carvedilol.
  • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses or syphilis infection.
  • Female volunteers demonstrating a positive pregnancy test.
  • Female volunteers who are currently breastfeeding.
  • Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  • Positive for urinary screen testing of drugs of abuse (opiates And cannabinoids)
  • Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  • Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).
  • Clinically abnormal ECG or Chest X-ray.
  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma, bronchial asthma, fainting or syncope.
  • History of any psychiatric illness which may impair the ability to provide written informed consent.
  • Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  • History of drug dependence or excessive alcohol intake on Habitual basis of more than 2 units of alcoholic beverages per day (1 Unit equivalent to half pint of beer or ! glass of wine or I measure of spirit) or have difficulty_ in abstaininq for the duration of each study period.
  • Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  • Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  • A haemoglobin concentration of less than 7 % of lower limit of reference range e.g. 13 gm % for reference range of 1448 gm at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Carvedilol 12.5 mg tablets
Drug: Carvedilol 12.5 mg tablets
bioequivalence Carvedilol fasting
Experimental: 1
Carvedilol 12.5 mg tablets
Drug: Carvedilol 12.5 mg tablets
bioequivalence Carvedilol fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 20, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021/CARVE-12.5/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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