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Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616863
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

Brief Summary:
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.

Condition or disease Intervention/treatment Phase
Epilepsy Seizures Drug: Oxcarbazepine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazapine 600 mg Tablets Under Fed Conditions
Study Start Date : July 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: Baseline, two period, 7 day washout ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • No clinically significant abnormal finding 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 advers response to oxcarbazepine or any other comparable or similar product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616863


Locations
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Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Roxane Laboratories
Investigators
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Principal Investigator: Gaetano Morrelli, MD MDS Pharma Services

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Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00616863    
Other Study ID Numbers: OXCA-02
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers