Mechanisms Underlying Drug-Diet Interactions
- Registration Number
- NCT01034124
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- 18-65 years of age
- Healthy
- Not taking medications known to modulate CYP2C9 and CYP3A activity
- Able to understand the consent process
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Water warfarin, vitamin K, midazolam - Cranberry juice warfarin, vitamin K, midazolam -
- Primary Outcome Measures
Name Time Method AUC 0-96 hr
- Secondary Outcome Measures
Name Time Method Cmax varies
Trial Locations
- Locations (1)
UNC-Chapel Hill General Clinical Research Center
🇺🇸Chapel Hill, North Carolina, United States