Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting 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):
Gaetano Morelli, MD, Principal Investigator, Affiliation: MDS Pharma Services
Summary
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.
Clinical Details
Official title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting 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 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.
Locations and Contacts
MDS Pharma Services, Montreal, Quebec H4R 2N6, Canada
Additional Information
Starting date: June 2004
Ending date: July 2004
Last updated: February 14, 2008
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