Status:
COMPLETED
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Seizures
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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, Trilept...
Eligibility Criteria
Inclusion
- No clinically significant abnormal finding on the physical examination, medical history, or clinical labratory results duirng screening
Exclusion
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to oxcarbazepne or any other comparable or similar product.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00616681
Start Date
June 1 2004
End Date
July 1 2004
Last Update
January 23 2018
Active Locations (1)
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1
MDS Pharma Services
Montreal, Quebec, Canada, H4R 2N6