Kidney Transplantation Clinical Trial
Official title:
An Open-label, Single-centre Study to Assess the Effect of Food on the Relative Bioavailability of Orally Administered Tacrolimus Modified Release Formulation, FK506E (MR4), in Stable Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast. The objective is to assess the pharmacokinetics and relative bioavailability with and without food.
Stable kidney transplant recipients who are participating in the clinical trial FG-506-14-02
and who are currently being treated with FK506E (MR4) under fasted conditions and who have
had no changes in any of their medications for at least seven days will be enrolled in the
sub-study. Following enrolment, all patients will remain on all their medication and the
same dosing regimen throughout the study.During the study two 24 hour blood concentration
time profiles will be collected, each one on the last day of Period 2 and Period 3 of the
sub-study as follows:
Profile 1 on Day 7 under fasted conditions
Profile 2 on Day 14 under non-fasted conditions
A total of five scheduled visits are planned.
At least 24 patients with two complete, evaluable profiles are needed to estimate the effect
of food on the oral bioavailability of FK506E (MR4).
Blood sampling - For each sample a 2 mL aliquot of whole blood will be collected. The total
blood volume for the two profiles taken per patient will be approximately 40 mL.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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