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CompletedNCT01034124Updated Dec 17, 2009

Mechanisms Underlying Drug-Diet Interactions

An interventional study of warfarin, vitamin K, midazolam in Pharmacokinetics, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-17.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Pharmacokinetics

Keywords

  • warfarin
  • midazolam
  • cranberry juice
  • pharmacokinetics
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Placebo comparator
    Water

    Drug: warfarin, vitamin K, midazolam

  • Active comparator
    Cranberry juice

    Drug: warfarin, vitamin K, midazolam

Interventions

  • Drugwarfarin, vitamin K, midazolam

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

    Also known as: Coumadin, Mephyton, Versed

06

What researchers measure

Primary outcomes

  1. AUC

    Time frame: 0-96 hr

Secondary outcomes

  1. Cmax

    Time frame: varies

07

Study locations

1 site
  • UNC-Chapel Hill General Clinical Research Center
    Chapel Hill, North Carolina 27599, United States
08

References and documents

Publications

  • Ngo N, Yan Z, Graf TN, Carrizosa DR, Kashuba AD, Dees EC, Oberlies NH, Paine MF. Identification of a cranberry juice product that inhibits enteric CYP3A-mediated first-pass metabolism in humans. Drug Metab Dispos. 2009 Mar;37(3):514-22. doi: 10.1124/dmd.108.024968. Epub 2008 Dec 29. PubMed 19114462 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01034124
Lead sponsor
University of North Carolina, Chapel Hill
First posted
Dec 17, 2009
Start date
Jan 2007
Primary completion
Nov 2007
Completion
Jun 2008
Last update
Dec 17, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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