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Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

This study has been completed.
Information provided by (Responsible Party):
Roxane Laboratories Identifier:
First received: October 5, 2012
Last updated: January 17, 2014
Last verified: January 2014
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions

Condition Intervention Phase
Drug: Oxcarbazepine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 10 days ]
    Blood sampling taken during specified time points to determine bioequivalence

Enrollment: 59
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxcarbazepine then Trileptal
600 mg suspension
Drug: Oxcarbazepine
Other Name: Trileptal
Active Comparator: Trileptal then Oxcarbazepine
600 mg suspension
Drug: Oxcarbazepine
Other Name: Trileptal


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during 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 oxcarbazepine or any comparable or similar product.
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Please refer to this study by its identifier: NCT01703468

United States, Texas
Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Cynthia Zamora, MD Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
  More Information

Responsible Party: Roxane Laboratories Identifier: NCT01703468     History of Changes
Other Study ID Numbers: OXCA-S600-PVFD-2
Study First Received: October 5, 2012
Last Updated: January 17, 2014

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators processed this record on May 25, 2017