Mechanisms Underlying Drug-Diet Interactions

Completed 19 enrolled University of North Carolina, Chapel Hill

RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start: 2007-01
Primary completion: 2007-11
Completion: 2008-06

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	5 mg	—
Comparator	Warfarin	Small molecule	10 mg	—
Comparator	Vitamin K	Unknown	10 mg	—

Indications

No indication recorded.