Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Completed · Not applicable

Conditions studied: Seizures, Epilepsy

In brief

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.

Key facts

Study ID

NCT00618046

Run by

Roxane Laboratories

People needed

48

Starts

2004-11-01

Expected to finish

2004-11-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

You may not qualify if…

• 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.

Where it is running

• Bio-Kinetics Clinical Applications, Inc . — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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