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Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01702623
First received: October 4, 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 fasted 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 Fasted 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 ]

Enrollment: 64
Study Start Date: September 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxcarbazepine first, then Trileptal
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period)
Drug: Oxcarbazepine
Other Name: Trileptal
Active Comparator: Trileptal first, then Oxcarbazepine
Single dose of oxcarbazepine suspension, 600 mg, then single dose of trileptal suspension, 600 mg (after washout period
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702623

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: NCT01702623     History of Changes
Other Study ID Numbers: OXCA-S600-PVFS-2
Study First Received: October 4, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carbamazepine
Oxcarbazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
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

ClinicalTrials.gov processed this record on November 24, 2014