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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: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01526213 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01526213 record still lists
NCT01526213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Fexofenadine is the first listed.
NCT01526213 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526213's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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