Mechanisms Underlying Drug-Diet Interactions

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Midazolam; Vitamin K; Vitamins; Warfarin

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