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NCT02574754 · ClinicalTrials.gov registry record · Phase 1
Assessment of 2012 Bioequivalence Standards for Warfarin
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02574754: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT02574754 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02574754, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the 2012 bioequivalence statistical criteria for warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food and Drug Administration (FDA).
Primary Outcome
The primary outcome measure will be warfarin area-under-the-concentration-time curve (AUC) values from zero to seventy-two (0-72) hours. Values from the Experimental Arm (warfarin) of each the 3 study periods will be compared against each other and analyzed for intra-individual variability and tested for bioequivalence using the new narrow therapeutic index drug (NTID) regulations. Blood collection at 0, 1, 2, 3, 4, 6, 8, 12 hours after warfarin dosing.
Interventions
- DRUG warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-05 |
| Est. Completion | 2019-02 |
| Phase | Phase 1 |
What the finished NCT02574754 record still lists
NCT02574754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which warfarin is the first listed.
NCT02574754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02574754 about?
NCT02574754 is a clinical study titled "Assessment of 2012 Bioequivalence Standards for Warfarin". The purpose of this study is to assess the 2012 bioequivalence statistical criteria for warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food and Drug Administration (FDA).
What is the current status of trial NCT02574754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-05. Estimated completion is 2019-02.
What interventions are being tested in trial NCT02574754?
The interventions under investigation include: warfarin (DRUG).
Who is sponsoring clinical trial NCT02574754?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02574754's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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