Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2007-01-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Water
warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Cranberry juice
warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Interventions
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warfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy
* Not taking medications known to modulate CYP2C9 and CYP3A activity
* Able to understand the consent process
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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The University of North Carolina, Chapel Hill
Principal Investigators
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Mary F Paine, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UNC-Chapel Hill
Locations
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UNC-Chapel Hill General Clinical Research Center
Chapel Hill, North Carolina, United States
Countries
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References
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Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29.
Other Identifiers
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UNC-CH 05-2951
Identifier Type: -
Identifier Source: org_study_id