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Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Primary Purpose

Seizures

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
Roxane Laboratories
About
Eligibility
Locations
Arms
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 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 then Trileptal

Trileptal then Oxcarbazepine

Arm Description

600 mg suspension

600 mg suspension

Outcomes

Primary Outcome Measures

bioequivalence determined by statistical comparison Cmax
Blood sampling taken during specified time points to determine bioequivalence

Secondary Outcome Measures

Full Information

First Posted
October 5, 2012
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01703468
Brief Title
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed 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
October 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 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
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxcarbazepine then Trileptal
Arm Type
Active Comparator
Arm Description
600 mg suspension
Arm Title
Trileptal then Oxcarbazepine
Arm Type
Active Comparator
Arm Description
600 mg suspension
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Other Intervention Name(s)
Trileptal
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Description
Blood sampling taken during specified time points to determine bioequivalence
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

Learn more about this trial

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

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