Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

This study has been completed.

First Received: January 31, 2008 Last Updated: February 15, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00618046

Purpose

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.

Condition	Intervention
Seizures Epilepsy	Drug: Oxcarbazepine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two Period, Seven day washout ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	November 2004
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618046

Locations

United States, Missouri
Bio-Kinetics Clinical Applications, Inc .
Springfield, Missouri, United States, 658902

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Dennis Morrison, D.O.

Bio-Kinetic Clinical Applications, Inc.

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	OXCA-T600-PVFD-2
Study First Received:	January 31, 2008
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00618046 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Tranquilizing Agents
Oxcarbazepine
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Diseases
Antimanic Agents
Brain Diseases
Pharmacologic Actions

Carbamazepine
Epilepsy
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010