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Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Primary Purpose

Seizures, Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxcarbazepine
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)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng 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 oxcarbazepne or any other comparable or similar product.

Sites / Locations

  • MDS Pharma Services

Outcomes

Primary Outcome Measures

Bioequivalence

Secondary Outcome Measures

Full Information

First Posted
February 4, 2008
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00616681
Brief Title
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
Official Title
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 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 the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.

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
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, 7 day washout

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 finding on the physical examination, medical history, or clinical labratory results duirng 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 oxcarbazepne or any other comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Morelli, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDS Pharma Services
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4R 2N6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

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