Mechanisms Underlying Drug-Diet Interactions
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...
Brief Summary
Official Title: “Mechanisms Underlying Drug-Diet Interactions”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
- Study Primary Completion Date: November 2007
Intervention(s) in this Clinical Trial
- Drug: warfarin, vitamin K, midazolam
- warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: Water
- Active Comparator: Cranberry juice
Outcome Measures for this Clinical Trial
Primary Measures
- AUC
- Time Frame: 0-96 hr
Safety Issue?: No
- Time Frame: 0-96 hr
Secondary Measures
- Cmax
- Time Frame: varies
Safety Issue?: No
- Time Frame: varies
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University of North Carolina, Chapel Hill Other
Overall Clinical Trial Officials and Contacts
Mary F Paine, Ph.D. Principal Investigator UNC-Chapel Hill
Related Publications
Citations Reporting Results
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. Epub 2008 Dec 29.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01034124
Study ID Number: UNC-CH 05-2951
ClinicalTrials.gov Identifier: NCT01034124
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01034124
