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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Danish Research Agency
Novartis
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00260247
First received: November 28, 2005
Last updated: NA
Last verified: March 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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.

Estimated Enrollment: 10
Study Start Date: April 2005
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260247

Locations
Denmark
University of Southern Denmark
Odense, Denmark, 5210
Sponsors and Collaborators
Odense University Hospital
Danish Research Agency
Novartis
Investigators
Principal Investigator: Per Damkier, MD, Ph.D. Odense University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260247     History of Changes
Other Study ID Numbers: AKF-315
Study First Received: November 28, 2005
Last Updated: November 28, 2005
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
CYP3A4
Induction
Oxcarbazepine
Carbamazepine
 Quinidine
Human
In vivo

Additional relevant MeSH terms:
Carbamazepine
Oxcarbazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013