Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Seizures
Intervention: Oxcarbazepine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Gaetano Morrelli, 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 with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet,
Trileptal, folloiwng 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 Oxcarbazapine 600 mg Tablets Under Fed Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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 during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or advers response to oxcarbazepine or any other comparable or
similar product.
Locations and Contacts
MDS Pharma Services, Montreal, Quebec H4R 2N6, Canada
Additional Information
Starting date: July 2004
Last updated: February 14, 2008
|