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NCT02127775 · ClinicalTrials.gov registry record · Phase 1
Lesinurad Tablet Bioequivalence
A Phase 1 study, sponsored by Ardea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT02127775: Completed Phase 1 study, sponsored by Ardea Biosciences.
NCT02127775 is a Phase 1 study that has completed, run by Ardea Biosciences. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127775, a Phase 1 study, has completed, sponsored by Ardea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
Primary Outcome
PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (tmax); area under the plasma concentration time curve from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations.
Interventions
- DRUG Lesinurad 400 mg (manufactured at Site 1)
- DRUG Lesinurad 400 mg (manufactured at Site 2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02127775 record still lists
NCT02127775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Lesinurad 400 mg (manufactured at Site 1) is the first listed.
NCT02127775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02127775 about?
NCT02127775 is a clinical study titled "Lesinurad Tablet Bioequivalence". This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
What is the current status of trial NCT02127775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2014-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02127775?
The interventions under investigation include: Lesinurad 400 mg (manufactured at Site 1) (DRUG), Lesinurad 400 mg (manufactured at Site 2) (DRUG).
Who is sponsoring clinical trial NCT02127775?
This trial is sponsored by Ardea Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02127775's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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