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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01132352
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Levetiracetam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2003
Study Completion Date: November 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Keppra® 750 mg Tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132352

Locations
United States, New Jersey
MDS Pharma Services
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Magdy L Shenouda, MD MDS Pharma Services
  More Information

No publications provided

Responsible Party: Mr. M.S. Mohan / Senior Manager - R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01132352     History of Changes
Other Study ID Numbers: AA06209
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Crossover
Levetiracetam

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014