Pharmacokinetics
Conditions
Keywords
warfarin, midazolam, cranberry juice, pharmacokinetics
Brief 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.
Interventions
DRUGwarfarin, vitamin K, midazolam
warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC | 0-96 hr |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | varies |
Countries
United States
Outcome results
None listed