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NCT02339246 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetic Comparison Of All FK-506 Formulations
A Phase 3 study, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT02339246: Completed Phase 3 study, sponsored by Veloxis Pharmaceuticals.
NCT02339246 is a Phase 3 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02339246, a Phase 3 study, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.
Primary Outcome
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max). Nominal time points used were: Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24. Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27. Astagraf XL sampling strategy (17
Interventions
- DRUG Prograf vs Envarsus XR vs Astagraf XL
- DRUG Prograf vs Astagraf XL vs Envarsus XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT02339246 record still lists
NCT02339246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Prograf vs Envarsus XR vs Astagraf XL is the first listed.
NCT02339246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02339246 about?
NCT02339246 is a clinical study titled "Pharmacokinetic Comparison Of All FK-506 Formulations". The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.
What is the current status of trial NCT02339246?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2015-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02339246?
The interventions under investigation include: Prograf vs Envarsus XR vs Astagraf XL (DRUG), Prograf vs Astagraf XL vs Envarsus XR (DRUG).
Who is sponsoring clinical trial NCT02339246?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02339246's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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