Bioequivalency Study of 600 mg Oxcarbazepine 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...
Brief Summary
Official Title: “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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2004
Intervention(s) in this Clinical Trial
- Drug: Oxcarbazepine
Outcome Measures for this Clinical Trial
Primary Measures
- Bioequivalence
- Time Frame: Baseline, Two period, 7 day washout
Safety Issue?: No
- Time Frame: Baseline, Two period, 7 day washout
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Roxane Laboratories Industry
Overall Clinical Trial Officials and Contacts
Gaetano Morelli, MD Principal Investigator MDS Pharma Services
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00616681
Study ID Number: OXCA-01
ClinicalTrials.gov Identifier: NCT00616681
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00616681
