Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions

June 11, 2010 updated by: Dr. Reddy's Laboratories Limited

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fed Conditions

The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • MDS Pharma Services

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy adult male volunteers, 18 to 55 years of age;
  • Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
  • Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
  • Voluntarily consent to participate in the study

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

  • In addition, history or presence of:

    1. alcoholism or drug abuse within the past 2 years;
    2. hypersensitivity or idiosyncratic reaction to levetiracetam;
  • Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
  • Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
  • Subjects who have made a plasma donation within 7 days prior to the first dose.
  • Subjects who have participated in another clinical trial within 30 days prior to the first dose.
  • Subjects with hemoglobin less than 12.0 g/dL.
  • Subjects who have participated in another clinical trial within 30 days prior to the first dose.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Drug: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other Names:
  • Keppra® 750 mg Tablets
Active Comparator: Keppra®
Keppra® 750 mg Tablets of UCB Pharma Inc.,
Drug: Levetiracetam
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Other Names:
  • Keppra® 750 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability based on Cmax and AUC parameters
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Dr. Reddy's Laboratories Limited

Investigators

  • Principal Investigator: Magdy L Shenouda, MD, MDS Pharma Services

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

September 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2010

Last Update Submitted That Met QC Criteria

June 11, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA06209

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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