Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)
Sandoz Investigative Site
Grenoble, France
Sandoz Investigative Site
Limoges, France
Sandoz Investigative Site
Nantes, France
AUC(0-τ)ss
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Time frame: Day 21 of each treatment period
Cmax,ss
Maximum whole blood concentration at steady state
Time frame: Day 21 of each treatment period
AUC(0-τ)ss
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Time frame: Day 14 of each treatment period
Cmax,ss
Maximum whole blood concentration at steady state
Time frame: Day 14 of each treatment period
Cmin,ss
Minimum whole blood concentration at steady state
Time frame: Days 14 and 21 of each treatment period
Cτ,ss
Concentration at the end of the dosing interval at steady state
Time frame: Days 14 and 21 of each treatment period
Cav
Average concentration during a dosing interval: AUC(0-τ)/τ
Time frame: Days 14 and 21 of each treatment period
Tmax,ss
Time to reach maximum (peak) plasma concentration at steady state
Time frame: Days 14 and 21 of each treatment period
AUC(0-τ)ss coefficient of variation
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Sandoz Investigative Site
Strasbourg, France
Sandoz Investigative Site
Suresnes, France
Sandoz Investigative Site
Toulouse, France
Sandoz Investigative Site
Tours, France
Sandoz Investigative Site
Berlin, Germany
Sandoz Investigative Site
Bochum, Germany
Sandoz Investigative Site
Essen, Germany
...and 3 more locations
Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-τ)ss coefficient of variation
Time frame: Days 14 and 21 of each treatment period
Cmax,ss coefficient of variation
Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation
Time frame: Days 14 and 21 of each treatment period
% Fluctuation
Degree of fluctuation of the analyte concentration levels over one dosing interval: 100\*(Cmax,ss - Cmin,ss)/Cav.
Time frame: Days 14 and 21 of each treatment period
%Swing
Degree of change of the analyte concentration levels over one dosing interval: 100\*(Cmax,ss - Cτ,ss)/Cτ,ss.
Time frame: Days 14 and 21 of each treatment period