Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Carbamazepine; Oxcarbazepine

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.