Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seizures; Epilepsy
Intervention: Oxcarbazepine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Dennis Morrison, D.O., Principal Investigator, Affiliation: Bio-Kinetic Clinical Applications, Inc.
Summary
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.
Clinical Details
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Bio-Kinetics Clinical Applications, Inc ., Springfield, Missouri 658902, United States
Additional Information
Starting date: November 2004
Ending date: November 2004
Last updated: February 15, 2008
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