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NCT02374164 · ClinicalTrials.gov registry record · Phase 1
Food Effect Study of Febuxostat XR in Healthy Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02374164: Completed Phase 1 study, sponsored by Takeda.
NCT02374164 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02374164, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
Primary Outcome
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.
Interventions
- DRUG Febuxostat XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT02374164 record still lists
NCT02374164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Febuxostat XR is the first listed.
NCT02374164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02374164 about?
NCT02374164 is a clinical study titled "Food Effect Study of Febuxostat XR in Healthy Participants". The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
What is the current status of trial NCT02374164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02374164?
The interventions under investigation include: Febuxostat XR (DRUG).
Who is sponsoring clinical trial NCT02374164?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02374164's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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