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Mechanisms Underlying Drug-Diet Interactions

NCT01034124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2009-12-17

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

warfarin, vitamin K, midazolam

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

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Mary F Paine, Ph.D. · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034124 on ClinicalTrials.gov