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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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: alcoholism or drug abuse within the past 2 years; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited | Drug: Levetiracetam<br>* Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited<br>* Other names: Keppra® 750 mg Tablets;|
| Active Comparator: Keppra®<br>Keppra® 750 mg Tablets of UCB Pharma Inc., | Drug: Levetiracetam<br>* Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited<br>* Other names: Keppra® 750 mg Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability based on Cmax and AUC parameters |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Crossover, Levetiracetam