Back to resultsBioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions
Primary Purpose
Seizures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Seizures
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.
Sites / Locations
- MDS Pharma Services
Outcomes
Primary Outcome Measures
bioequivalance based on Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00826787
Brief Title
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed 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 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
29 (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
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
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 Fed Conditions
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