Back to resultsCrossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Primary Purpose
Seizures
Status
Completed
Phase
Phase 1
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 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 oxcarbazepine or any comparable or similar product.
Sites / Locations
- Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxcarbazepine first, then Trileptal
Trileptal first, then Oxcarbazepine
Arm Description
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01702623
Brief Title
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 Roxane Laboratories' Oxcarbazepine Suspension 600 mg 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
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxcarbazepine first, then Trileptal
Arm Type
Active Comparator
Arm Description
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
Arm Title
Trileptal first, then Oxcarbazepine
Arm Type
Active Comparator
Arm Description
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Other Intervention Name(s)
Trileptal
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison 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 oxcarbazepine or any comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Zamora, MD
Organizational Affiliation
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
12. IPD Sharing Statement
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Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
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