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Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting 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)FemaleAccepts 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

  • MDS Pharma Services

Outcomes

Primary Outcome Measures

bioequivalance 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
NCT00826865
Brief Title
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (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 750 mg Tablets under fasted 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
27 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
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
Mark Allison, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

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