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Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients

NCT02014103 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-10-15

Study results available
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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.

Conditions

  • Complication of Transplant

Interventions

DRUG

Prograf

Administration of each formulation will be determined by sequence.

DRUG

Tacrolimus, Sandoz

Administration of each formulation will be determined by sequence.

DRUG

Tacrolimus, Reddy Laboratory

Administration of each formulation will be determined by sequence.

DRUG

Tacrolimus, Mylan

Administration of each formulation will be determined by sequence.

DRUG

Tacrolimus, Accord

Administration of each formulation will be determined by sequence.

DRUG

Tacrolimus, Pancea Biotech Limited

Administration of each formulation will be determined by sequence.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Rita R Alloway, PharmD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014103 on ClinicalTrials.gov