Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions

October 17, 2008 updated by: Ranbaxy Laboratories Limited

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Atenolol 100 mg Capsules in Healthy Volunteers

The purpose of this study was to determine the bioequivalence of atenolol formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on atenolol comparing atenolol 100mg tablets of Ranbaxy with Tenormin 100mg capsules in healthy, adult, human, subjects under fasting conditions.

A total of 36 non-smoking subjects (26 men and 10 women) were included in this study, of which 35 finished the study according to the protocol,

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapell Hill, North Carolina, United States, 27517
        • aaiPharma, Inc. -AAI Clinic

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects at least 18 years of age.
  2. Informed of the nature of the study and given written informed consent.
  3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds.

Exclusion Criteria:

  1. Hypersensitivity to Atenolol (Tenormin®) or related compounds such as propranolol (Inderal®).
  2. Conditions that affect the absorption, metabolism or passage of drugs out of the body, e.g., sprue, celiac disease, Crohn's disease, colitis, liver, kidney or thyroid conditions.
  3. Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism.
  4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  5. Received an investigational drug within the 4 weeks prior to study dosing.
  6. Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. Any nonprescription medication consumption reported will be reviewed by the investigator(s) prior to dosing. At the discretion of the investigator(s), these volunteers may be enrolled if the medication is not anticipated to alter study integrity.
  7. Regular smoking of more than 5 cigarettes daily or the daily use of nicotine-containing products beginning 3 months before study medication administration through the final evaluation.
  8. If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives/patches, progestin injection or implants, condom with spermacide, diaphragm with spermacide, IUD, vaginal spermicidal/hormonal suppository, surgical sterilization of themselves or their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
atenolol 100 mg Capsules of Ranbaxy
Drug: Atenolol 100mg Tablets
ACTIVE_COMPARATOR: 2
Tenormin 100mg capsules
Drug: Atenolol 100mg Tablets

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

May 1, 2005

Primary Completion (ACTUAL)

May 1, 2005

Study Completion (ACTUAL)

July 1, 2005

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

  • AAI-US-310

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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