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(IPCOM) Influence of Proton pump inhibitor CO-medication on the absorption of innovator and generic formulations of Mycophenolate mofetil

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517043-32-00
Acronym
2024-517043-32-00
Enrollment
12
Registered
2025-02-28
Start date
2025-07-08
Completion date
2025-11-18
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Transplantation Patients

Brief summary

As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.

Interventions

DRUGPantoprazole Teva 40 mg maagsapresistente tabletten
DRUGMycophenolate mofetil Sandoz 500 mg Film-coated Tablets
DRUGMycophenolate Mofetil Accord 500 mg plėvele dengtos tabletės

Sponsors

Leids Universitair Medisch Centrum (LUMC)
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
As primary endpoint the C-max and the area under the concentration-time curve (AUC)(0-12) of MPA will be calculated. Comparisons will be made between the three formulations in AUC according to the criteria for demonstrating bio-equivalence.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026