Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Roxane Laboratories |
---|---|
Information provided by: | Roxane Laboratories |
ClinicalTrials.gov Identifier: | NCT00618046 |
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.
Condition | Intervention |
---|---|
Seizures Epilepsy |
Drug: Oxcarbazepine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions |
Enrollment: | 48 |
Study Start Date: | November 2004 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Bio-Kinetics Clinical Applications, Inc . | |
Springfield, Missouri, United States, 658902 |
Principal Investigator: | Dennis Morrison, D.O. | Bio-Kinetic Clinical Applications, Inc. |
Responsible Party: | Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs ) |
Study ID Numbers: | OXCA-T600-PVFD-2 |
Study First Received: | January 31, 2008 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00618046 |
Health Authority: | United States: Institutional Review Board |
Oxcarbazepine Malnutrition Carbamazepine Epilepsy |
Seizures Central Nervous System Diseases Brain Diseases |
Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |