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Mechanisms Underlying Drug-Diet Interactions

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: warfarin, vitamin K, midazolam (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Mary F Paine, Ph.D., Principal Investigator, Affiliation: UNC-Chapel Hill

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.

Clinical Details

Official title: Mechanisms Underlying Drug-Diet Interactions

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: AUC

Secondary outcome: Cmax

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

UNC-Chapel Hill General Clinical Research Center, Chapel Hill, North Carolina 27599, United States
Additional Information

Starting date: January 2007
Last updated: December 15, 2009

Page last updated: August 23, 2015

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