Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Roxane Laboratories Identifier:
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: February 2008

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
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:

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)

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

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 identifier: NCT00616681

Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Roxane Laboratories
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. 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:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on April 22, 2014