interventional
N/A
1 country
1
To demonstrate bioequivalence between Test and Reference products.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2023
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cmax and AUC0-t of Tofacitinib will be the primary pharmacokinetic parameters.
tmax, AUC0-∞, %AUCextrap, λz and t1/2 of Tofacitinib will be the secondary pharmacokinetic parameters.
Occurrence of adverse events (AEs), including clinically relevant abnormalities from clinical laboratory tests and vital signs.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Tofacitinib
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
XELJANZ 10 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.
Tofacitinib
Named ingredient: tofacitinib
View registry recordXELJANZ 10 mg film-coated tablets
Named ingredient: tofacitinib
View registry recordBlueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, 4250-449, Portugal
Medical Affairs - Bluepharma Indústria Farmacêutica, S.A
First Submitted
September 26, 2023
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
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:
Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare
Contact the study team to confirm eligibility.