Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00827320
NCT00827320CompletedNot Applicable

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

Roxane Laboratories2 sites in 1 country26 target enrollmentStarted: June 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
bioequivalence based on Cmax
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

bioequivalence based on Cmax

Time Frame: 10 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Bioequivalency Study of Levetiracetam 1g Under Fasted ConditionsSeizures
NCT00826722Roxane Laboratories30
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed ConditionsSeizures
NCT00826787Roxane Laboratories29
Completed
Not Applicable
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting ConditionsSeizures
NCT00826865Roxane Laboratories27
Completed
Phase 1
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in ChineseHuman Volunteers
NCT01618903UCB Pharma24
Completed
Not Applicable
A Bioequivalence Study of Levetiracetam Versus KeppraHealthy
NCT00926302Tri-Service General Hospital26
Bioequivalency Study of Levetiracetam 1g... | Clinical Trial