Skip to main content
OpenTrials
Completed

NCT Number: NCT01034124

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.

Completed

Looking for future studies?

Notify Me

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

  1. AUC

    Time frame: 0-96 hr

Secondary outcomes

  1. Cmax

    Time frame: varies

Interested in participating?

Completed

Looking for future studies?

Notify Me

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.

Related clinical trials

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