Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

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.

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.