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Completed

NCT Number: NCT00827320

Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions

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Key information

Conditions

Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Treatment and study plan

Levetiracetam

Drug

1000 mg tablet

Other names: KEPPRA

Primary outcomes

  1. bioequivalence based on Cmax

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 22, 2009
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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