Status:

COMPLETED

Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

Lead Sponsor:

Roxane Laboratories

Conditions:

Seizures

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2007

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00826722

Start Date

June 1 2007

End Date

June 1 2007

Last Update

January 23 2018

Active Locations (1)

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Novum Pharmaceutical Research Services

Houston, Texas, United States, 77042