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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01132352
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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.

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 Timeline

• Study Start: 2003-09
• Primary Completion: 2003-10
• Study Completion: 2003-11
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-11
• Last Update Posted: 2010-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Keppra®	Levetiracetam	Keppra® 750 mg Tablets of UCB Pharma Inc.,

Primary Outcome Measures

Name	Time	Method
Bioavailability based on Cmax and AUC parameters	3 months

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Neptune, New Jersey, United States