Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Roxane Laboratories

Status: Completed

Conditions: Seizures; Epilepsy

Treatments: Drug: Oxcarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00618046

OXCA-T600-PVFD-2

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)