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