Mechanisms Underlying Drug-Diet Interactions

University of North Carolina (UNC)

Status: Completed

Conditions: Pharmacokinetics

Treatments: Drug: warfarin, vitamin K, midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01034124

UNC-CH 05-2951

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups, including a placebo group

Water

Placebo Comparator group

Treatment:

Drug: warfarin, vitamin K, midazolam

Cranberry juice

Active Comparator group

Treatment:

Drug: warfarin, vitamin K, midazolam