Status:
COMPLETED
Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Food-drug Interaction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Purpose: Grapefruit juice is one of the most extensively studied dietary/natural substances shown to interact with a variety of medications. However, unanswered questions remain regarding the causativ...
Detailed Description
Participants: Healthy volunteers of any race/ethnicity, ranging in age from 18 to 65 years, will be enrolled. Procedures (methods): Procedures will include administration of water, furanocoumarin-fre...
Eligibility Criteria
Inclusion
- Men or women between the ages of 18 and 65
- Normal screening laboratory test results
- Able to understand the informed consent form
- Willing to abstain from grapefruit products and all fruit juices for one week prior to and during the study
- Willing to abstain from alcohol and caffeinated beverages the evening prior to each study day
Exclusion
- History of intolerance to grapefruit products
- History of any allergy or hypersensitivity to grapefruit products or fexofenadine
- History of significant medical conditions that the study physician believes would increase risk
- History of significant alcohol abuse and/or illicit drug use
- Tobacco use within the month preceding the study
- Pregnancy or breast-feeding
- Taking concomitant medications, both prescription and non-prescription (including herbal products), known to alter fexofenadine blood levels or P-gp and/or OATP activity (women stabilized on hormonal methods of birth control will be allowed to participate)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01526213
Start Date
September 1 2009
End Date
April 1 2011
Last Update
May 30 2017
Active Locations (1)
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1
North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, United States, 27599