At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 20 enrolled
Drug / intervention
Mycophenolate sodium +2 moredrug
Likely dose
Mycophenolate sodium 720mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Mycophenolate sodium, Pantoprazole, and 1 other intervention for Transplantation and 2 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransplantation, Immunosuppression, Drug Interaction
CountriesGermany
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedFeb 2013
Primary CompletionMar 2013
Study CompletionMar 2014
TodayJul 2026
First PostedFeb 28, 2013
Enrollment StartJan 1, 2012
Primary CompletionMar 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.3 years ago
Interventions
Mycophenolate sodiumdrug
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Pantoprazoledrug
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Mycophenolate mofetildrug
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .