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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Etiracetam; Levetiracetam; Piracetam

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.