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NCT01526213 · ClinicalTrials.gov registry record · NA
Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT01526213 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants.
The verdict
NCT01526213, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fexofenadine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01526213
The ClinicalTrials.gov registry entry for NCT01526213 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fexofenadine is the first listed.
NCT01526213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01526213 about?
NCT01526213 is a clinical study titled "Do Furanocoumarins Mediate the Fexofenadine-grapefruit Juice Interaction?". 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 grapef...
What is the current status of trial NCT01526213?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2009-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01526213?
The interventions under investigation include: Fexofenadine (DRUG).
Who is sponsoring clinical trial NCT01526213?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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