Overview
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Status:
Completed
Completed
Trial end date:
2009-10-01
2009-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditionsPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Roxane LaboratoriesTreatments:
Carbamazepine
Oxcarbazepine
Criteria
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.