Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

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.

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.