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NCT04725682 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Tacrolimus in Healthy Volunteers
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT04725682: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT04725682 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725682, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions. The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.
Primary Outcome
Measurement of whole blood tacrolimus prior to dosing and up to 72 hours post-dose
Interventions
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2021-06-17 |
| Phase | Phase 1 |
What the finished NCT04725682 record still lists
NCT04725682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus is the first listed.
NCT04725682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04725682 about?
NCT04725682 is a clinical study titled "Bioequivalence Study of Tacrolimus in Healthy Volunteers". This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditi...
What is the current status of trial NCT04725682?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2021-01-05. Estimated completion is 2021-06-17.
What interventions are being tested in trial NCT04725682?
The interventions under investigation include: Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT04725682?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04725682's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 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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