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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.

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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

FieldValue
Enrollment Target 71 participants
Start Date 2015-03
Est. Completion 2015-08
Phase Phase 4

Sponsor

University of Cincinnati

245 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.