Official Title: “A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: November 2004

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• Bioequivalence
  • Time Frame: Baseline, Two Period, Seven day washout
    Safety Issue?: No

Inclusion Criteria:

• No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with any known enzyme altering drugs.
• History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Lead Sponsor: Roxane Laboratories

Overall Clinical Trial Officials and Contacts

Dennis Morrison, D.O. Principal Investigator Bio-Kinetic Clinical Applications, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618046

Study ID Number: OXCA-T600-PVFD-2

ClinicalTrials.gov Identifier: NCT00618046

Health Authority: United States: Institutional Review Board