Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

This study has been completed.

First Received on February 4, 2008. Last Updated on February 14, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00616681

Purpose

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.

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, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting 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, 7 day washout ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	June 2004
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616681

Locations

Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R 2N6

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Gaetano Morelli, MD

MDS Pharma Services

More Information

No publications provided

Responsible Party:	Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00616681 History of Changes
Other Study ID Numbers:	OXCA-01
Study First Received:	February 4, 2008
Last Updated:	February 14, 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