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Clinical Trials/NCT00260247
NCT00260247CompletedPhase 4

Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

Odense University Hospital2 sites in 1 country10 target enrollmentStarted: April 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Formation clearance of 3-hydroxyquinidine
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.

It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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 Criteria

  • •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

Outcomes

Primary Outcomes

Formation clearance of 3-hydroxyquinidine

Secondary Outcomes

  • Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Investigators

Sponsor Class
Other

Study Sites (2)

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