Back to resultsBioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Primary Purpose
Seizures, Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Seizures
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with any known enzyme altering drugs.
- History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.
Sites / Locations
- Bio-Kinetics Clinical Applications, Inc .
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00618046
Brief Title
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (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 assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two Period, Seven day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.
Exclusion Criteria:
Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with any known enzyme altering drugs.
History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Morrison, D.O.
Organizational Affiliation
Bio-Kinetic Clinical Applications, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bio-Kinetics Clinical Applications, Inc .
City
Springfield
State/Province
Missouri
ZIP/Postal Code
658902
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
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