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Sponsored by: |
Roxane Laboratories |
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Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00616681 |
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.
Condition | Intervention |
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Seizures Epilepsy |
Drug: Oxcarbazepine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | OXCA-01 |
Study First Received: | February 4, 2008 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00616681 History of Changes |
Health Authority: | United States: Institutional Review Board |
Oxcarbazepine Epilepsy Seizures |
Central Nervous System Diseases Brain Diseases Anticonvulsants |
Oxcarbazepine Epilepsy Therapeutic Uses Nervous System Diseases Central Nervous System Diseases |
Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |