SYFb61ee59277314841b1423f6e88514831Registry ID: 2023-508339-29-00|UnknownPhase 1Results
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interventional
N/A
1 country
1
To compare the bioavailability between Test and Reference products.
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.
October 24, 2023
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Cmax and AUC0-t of Ruxolitinib will be the primary pharmacokinetic parameters.
tmax, AUC0-∞, %AUCextrap, λz and t1/2 of Ruxolitinib will be the socondary pharmacokinetic parameters.
Occurrence of treatment-emergent adverse events (TEAEs), including clinically relevant abnormalities on vital signs or clinical laboratory tests.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Jakavi 20 mg tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Jakavi 20 mg tablets
Named ingredient: ruxolitinib
View registry recordBlueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, 4250-449, Portugal
Medical Affairs - Bluepharma Indústria Farmacêutica, S.A
First Submitted
October 24, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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