Conditions: Renal Failure
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Prograft capsules Twice daily for 7 days, followed by Envarsus XR tablets once daily for 7 days followed by Astagraf XL capsules once daily for 7 days. arm 2: Prograf capsules twice daily for 7 days followed by Astagraf XL capsules once daily for 7 days followed by Envarsus XR tablets once daily.

Interventions: intervention 1: Prograf vs Envarsus XR vs Astagraf XL intervention 2: Prograf vs Astagraf XL vs Envarsus XR
Intervention descriptions: intervention 1: prograf vs Envarsus XR vs Astagraf XL intervention 2: Prograf vs Astagraf XL vs Envarsus XR

Protocol document: