Status:
COMPLETED
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Danish Research Agency
Novartis
Conditions:
Metabolic Clearance Rate
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief Summary
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and...
Eligibility Criteria
Inclusion
- BMI \< 30
- Non smoker
- No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
- Informed consent
Exclusion
- signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
- mental disease
- participation in another clinical trial involving drugs with 3 months of randomization
- donation of more than 500 mL blood within 3 months of randomization
- intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00260247
Start Date
April 1 2005
End Date
October 1 2006
Last Update
April 22 2015
Active Locations (1)
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1
University of Southern Denmark
Odense, Denmark, 5210