Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Endpoint Classification: Bio-equivalence Study
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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Antimanic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Tranquilizing Agents
Voltage-Gated Sodium Channel Blockers processed this record on March 03, 2015