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

NCT01801280 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-21

Study results available
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Summary

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

Conditions

  • Transplantation
  • Immunosuppression
  • Drug Interaction

Interventions

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® .

Sponsors & Collaborators

Principal Investigators

  • Klemens Budde, Prof Dr · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801280 on ClinicalTrials.gov