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OpenTrials
Completed

NCT Number: NCT01131897

Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting 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 Fasting conditions.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Neptune City, New Jersey, 07753, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • alcoholism or drug abuse within the past 2 years;
  • 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.

Treatment and study plan

Levetiracetam

Drug

Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited

Other names: Keppra® 750 mg Tablets

Primary outcomes

  1. Bioavailability based on Cmax and AUC parameters

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Dr. Reddy's Laboratories Limited

Industry

Registry information

Official study 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 Fasting Conditions.

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
May 27, 2010
Registry last updated
Jun 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.