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Mechanisms Underlying Drug-Diet Interactions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034124
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.

Condition Intervention
Pharmacokinetics Drug: warfarin, vitamin K, midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanisms Underlying Drug-Diet Interactions

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • AUC [ Time Frame: 0-96 hr ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: varies ]

Enrollment: 19
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Water Drug: warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other Names:
  • Coumadin
  • Mephyton
  • Versed
Active Comparator: Cranberry juice Drug: warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other Names:
  • Coumadin
  • Mephyton
  • Versed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Healthy
  • Not taking medications known to modulate CYP2C9 and CYP3A activity
  • Able to understand the consent process

Exclusion Criteria:

  • Allergy to cranberry products, warfarin, vitamin K, or midazolam
  • Pregnant or breast-feeding women
  • Baseline INR >1.2
  • History of significant medical conditions that could increase risk
  • Concomitant medications known to modulate CYP2C9 and CYP3A activity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034124


Locations
United States, North Carolina
UNC-Chapel Hill General Clinical Research Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Mary F Paine, Ph.D. UNC-Chapel Hill
  More Information

Publications:
Responsible Party: Mary F. Paine, The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01034124     History of Changes
Other Study ID Numbers: UNC-CH 05-2951
First Submitted: December 15, 2009
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
Last Verified: December 2009

Keywords provided by University of North Carolina, Chapel Hill:
warfarin
midazolam
cranberry juice
pharmacokinetics

Additional relevant MeSH terms:
Vitamins
Vitamin K
Midazolam
Warfarin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants