Mechanisms Underlying Drug-Diet Interactions
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: warfarin, vitamin K, midazolam (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): Mary F Paine, Ph.D., Principal Investigator, Affiliation: UNC-Chapel Hill
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.
Clinical Details
Official title: Mechanisms Underlying Drug-Diet Interactions
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUC
Secondary outcome: Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
UNC-Chapel Hill General Clinical Research Center, Chapel Hill, North Carolina 27599, United States
Additional Information
Starting date: January 2007
Last updated: December 15, 2009
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