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Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

This study has been completed.
Danish Research Agency
Information provided by:
Odense University Hospital Identifier:
First received: November 28, 2005
Last updated: April 21, 2015
Last verified: March 2005

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.

Condition Intervention Phase
Metabolic Clearance Rate Drug: carbamazepine oxcarbazepine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Formation clearance of 3-hydroxyquinidine

Secondary Outcome Measures:
  • Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Enrollment: 10
Study Start Date: April 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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
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Please refer to this study by its identifier: NCT00260247

University of Southern Denmark
Odense, Denmark, 5210
Sponsors and Collaborators
Odense University Hospital
Danish Research Agency
Principal Investigator: Per Damkier, MD, Ph.D. Odense University Hospital
  More Information Identifier: NCT00260247     History of Changes
Other Study ID Numbers: AKF-315
Study First Received: November 28, 2005
Last Updated: April 21, 2015

Keywords provided by Odense University Hospital:
In vivo

Additional relevant MeSH terms:
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators processed this record on September 21, 2017