Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 45
Updated:1/25/2018
Start Date:September 2009
End Date:October 2009

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A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Oxcarbazepine Suspension 600 mg under fed conditions


Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during 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 oxcarbazepine or any comparable or similar
product.
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