Mechanisms Underlying Drug-Diet Interactions

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC-Chapel Hill General Clinical Research Center

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

warfarin, vitamin K, midazolam

Drug

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

Other names: Coumadin, Mephyton, Versed

Primary outcomes

AUC

Time frame: 0-96 hr

Secondary outcomes

Cmax

Time frame: varies

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2008
First posted: Dec 17, 2009
Registry last updated: Dec 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed