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Pharmacokinetic Comparison Of All FK-506 Formulations

NCT02339246 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-01-18

Study results available
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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.

Conditions

  • Renal Failure

Interventions

DRUG

Prograf vs Envarsus XR vs Astagraf XL

prograf vs Envarsus XR vs Astagraf XL

DRUG

Prograf vs Astagraf XL vs Envarsus XR

Prograf vs Astagraf XL vs Envarsus XR

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rita Alloway, PharmD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT02339246 on ClinicalTrials.gov