Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01703468
First received: October 5, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions


Condition Intervention Phase
Seizures
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703468

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

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov 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:
Seizures
Epilepsy
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 April 17, 2014