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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Levetiracetam

• Registration Number: NCT01131897
• 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 Fasting conditions.

Detailed Description

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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2003-09
• Study Completion: 2003-11
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• 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
Keppra®	Levetiracetam	Keppra® 750 mg Tablets of UCB Pharma Inc.,
Levetiracetam	Levetiracetam	Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited

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