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Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

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: Food-drug Interaction

Intervention: Fexofenadine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

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

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 causative ingredients and mechanisms underlying such drug-grapefruit juice interactions. Compounds in grapefruit juice called furanocoumarins have been established as major causative ingredients, which act by inhibiting the elimination (metabolism) of drugs, leading to increased circulating drug concentrations. Increased drug concentrations can in turn lead to increased drug potency or even toxicity. Grapefruit juice also has been shown, paradoxically, to decrease circulating concentrations of some drugs, including the non-sedating antihistamine agent, fexofenadine (Allegra), which undergoes negligible metabolism. Whether or not furanocoumarins mediate the decrease in fexofenadine concentrations is unknown. The purpose of the proposed study is to compare the effects of a "furanocoumarin-free" grapefruit juice with grapefruit juice on circulating concentrations of fexofenadine.

Clinical Details

Official title: Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?

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

Primary outcome: Primary Pharmacokinetic Measure: Area Under the Curve (AUC)

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-free grapefruit juice, or grapefruit juice with fexofenadine; placement of an intravenous (IV) line; and collection of blood over 72 hours.

Eligibility

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

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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)

Locations and Contacts

North Carolina Clinical and Translational Research Center, Chapel Hill, North Carolina 27599, United States
Additional Information

Starting date: September 2009
Last updated: December 29, 2012

Page last updated: August 23, 2015

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