Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

This study has been completed.

First Received on January 31, 2008. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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 Malnutrition 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:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00618046 History of Changes
Other Study ID Numbers:	OXCA-T600-PVFD-2
Study First Received:	January 31, 2008
Last Updated:	February 15, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012