Clinical Trials Directory

Trials / Completed

CompletedNCT02339246

Pharmacokinetic Comparison Of All FK-506 Formulations

A Steady-state Pharmacokinetic Comparison Of All FK-506 Formulations

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Veloxis Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

The pharmacokinetic parameters T(max), C(max) and AUC(0-24) will be compared between the three formulations Envarsus XR once daily, Astagraf XL once daily and Prograf Twice daily.

Conditions

Interventions

TypeNameDescription
DRUGPrograf vs Envarsus XR vs Astagraf XLprograf vs Envarsus XR vs Astagraf XL
DRUGPrograf vs Astagraf XL vs Envarsus XRPrograf vs Astagraf XL vs Envarsus XR

Timeline

Start date
2015-01-01
Primary completion
2015-03-01
Completion
2015-03-01
First posted
2015-01-15
Last updated
2016-01-18
Results posted
2016-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02339246. Inclusion in this directory is not an endorsement.