Mechanisms Underlying Drug-Diet Interactions

University of North Carolina, Chapel Hill19 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

warfarin, vitamin K, midazolamDRUG

warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

UNC-Chapel Hill General Clinical Research Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

AUC

Time frame: 0-96 hr

Secondary Outcomes

Cmax

Time frame: varies

Data from ClinicalTrials.gov

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