Mechanisms Underlying Drug-Diet Interactions

University of North Carolina (UNC) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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