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

NCT ID: NCT01131897

Last Updated: 2010-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2003-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

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

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

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

Keppra®

Keppra® 750 mg Tablets of UCB Pharma Inc.,

Group Type: ACTIVE_COMPARATOR

Levetiracetam

Intervention Type: DRUG

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

Interventions

Levetiracetam

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

Intervention Type: DRUG

Other Intervention Names

Keppra® 750 mg Tablets

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Magdy L Shenouda, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Neptune City, New Jersey, United States

Countries

United States

Other Identifiers

AA06179

Identifier Type: -

Identifier Source: org_study_id