NCT01801280

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Pharmacokinetic Cross-over Study to Evaluate the Influence of Pantoprazole on MPA Bioavailability Administered as Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Maintenance Renal Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Klemens Budde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Transplantation
• Immunosuppression
• Drug Interaction

Interventions

Type	Name	Description
DRUG	Mycophenolate sodium	Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
DRUG	Pantoprazole	Daily dose: 40mg. Application together with CellCept® or Myfortic® .
DRUG	Mycophenolate mofetil	Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2014-03-01
• First posted: 2013-02-28
• Last updated: 2019-02-21
• Results posted: 2016-09-09

Locations

1 site across 1 country: Germany