Mechanisms Underlying Drug-Diet Interactions

Completed · Not applicable

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT01034124

Run by

University of North Carolina, Chapel Hill

People needed

19

Starts

2007-01-01

Expected to finish

2008-06-01

Last updated by the study team

2009-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• UNC-Chapel Hill General Clinical Research Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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