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

01:54 EST 1st March 2015 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Levetiracetam

Location

MDS Pharma Services
Neptune
New Jersey
United States
07753

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

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PubMed Articles [28 Associated PubMed Articles listed on BioPortfolio]

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Several studies have reported rhabdomyolysis induced by various drugs but not by the antiepileptic drug levetiracetam. We present a case of suspected levetiracetam-induced rhabdomyolysis. A 29-year-ol...

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Medical and Biotech [MESH] Definitions

None available.

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