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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 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 67 participants.
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.
Interventions
- DRUG Tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2021-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04725682
The ClinicalTrials.gov registry entry for NCT04725682 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus is the first listed.
NCT04725682 reports 0 study locations.
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.
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