Conditions: Transplantation Immunosuppression Drug Interaction
Keywords: immunosuppressive medication mycophenolic acid interaction proton pump inhibitor pantoprazole renal transplant patients pharmacokinetics pharmacodynamics bioavailability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: no

Brief summary:
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.

Detailed description:
It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).

Arms:
arm 1: Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks. arm 2: Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks. arm 3: Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks. arm 4: Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.

Interventions: intervention 1: Mycophenolate sodium intervention 2: Pantoprazole intervention 3: Mycophenolate mofetil
Intervention descriptions: intervention 1: Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®. intervention 2: Daily dose: 40mg. Application together with CellCept® or Myfortic® . intervention 3: Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .

Protocol document: