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Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00616681
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: February 2008

February 4, 2008
February 14, 2008
June 2004
July 2004   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, Two period, 7 day washout ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616681 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions

The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Seizures
  • Epilepsy
Drug: Oxcarbazepine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng 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 oxcarbazepne or any other comparable or similar product.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00616681
OXCA-01
No
Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Gaetano Morelli, MD MDS Pharma Services
Roxane Laboratories
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP