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

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 Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01132352

Enrollment

Registered

2010-05-28

Start date

2003-09-30

Completion date

2003-11-30

Last updated

2010-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, Crossover, Levetiracetam

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.

Interventions

DRUGLevetiracetam

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioavailability based on Cmax and AUC parameters	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026