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Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Primary Purpose

Seizures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
Roxane Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novum Pharmaceutical Research Services

Outcomes

Primary Outcome Measures

bioequivalence based on Cmax

Secondary Outcome Measures

Full Information

First Posted
January 15, 2009
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00827320
Brief Title
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roxane Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
KEPPRA
Intervention Description
1000 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence based on Cmax
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soran Hong, MD
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

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