Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | November 2004 |
| End Date: | November 2004 |
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
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.
oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine
tablet, Trileptal, following a single 600 mg dose, administered with food.
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.
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