SYFb99c823714d6471baab71da715ac683bRegistry ID: 2025-521800-22-00|UnknownPhase 4
Immunosuppressive drug bioequivalence in kidney transplant recipients – Prograf and CellCept
Oslo University Hospital HFCTIS (EMA)
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interventional
N/A
1 country
1
Assess oral bioequivalence of generic Tac and MMF in kidney transplant recipients at steady-state.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2025
Actual (reported)AUC0-12 and Cmax of Tac and MPA test:reference (according to EMA bioequivalence guidelines).
Tac and MMF pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, popPK model parameters, metagenomic feces analyses, feces derived ex vivo drug conversion rates.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Tacrolimus Ascend 1 mg Hartkapseln
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Mycophenolate Mofetil Accord 250 mg kapselit
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
PROGRAF 1 mg capsule
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
CellCept 500 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Tacrolimus Ascend 1 mg Hartkapseln
Named ingredient: Tacrolimus
View registry recordMycophenolate Mofetil Accord 250 mg kapselit
Named ingredient: Mycophenolate mofetil
View registry recordPROGRAF 1 mg capsule
Named ingredient: Tacrolimus
View registry recordCellCept 500 mg film-coated tablets
Named ingredient: Mycophenolate mofetil
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Oslo University Hospital HF
Oslo, 0372, Norway
Anders Åsberg
First Submitted
April 16, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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