Expired Study
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Neptune, New Jersey 07753


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT01131897


Primary Contact:

Principal Investigator
Magdy L Shenouda, MD
MDS Pharma Services


Backup Contact:

N/A


Location Contact:

Neptune, New Jersey 07753
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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