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NCT02014103 · ClinicalTrials.gov registry record · Phase 4
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT02014103 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 71 participants.
The verdict
NCT02014103, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
Interventions
- DRUG Prograf
- DRUG Tacrolimus, Sandoz
- DRUG Tacrolimus, Reddy Laboratory
- DRUG Tacrolimus, Mylan
- DRUG Tacrolimus, Accord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02014103
The ClinicalTrials.gov registry entry for NCT02014103 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Prograf is the first listed.
NCT02014103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02014103 about?
NCT02014103 is a clinical study titled "Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients". The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
What is the current status of trial NCT02014103?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2015-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02014103?
The interventions under investigation include: Prograf (DRUG), Tacrolimus, Sandoz (DRUG), Tacrolimus, Reddy Laboratory (DRUG), Tacrolimus, Mylan (DRUG), Tacrolimus, Accord (DRUG).
Who is sponsoring clinical trial NCT02014103?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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