SYF3e6465fb66cb45e291fa242367da1a01Registry ID: 2023-503557-35-00|UnknownPhase 1Results
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interventional
N/A
1 country
1
To evaluate the relative bioavailability of the test formulation of apixaban tablets compared to the commercial formulations taken as reference and to demonstrate their bioequivalence according to health authorities’ criteria.
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.
March 6, 2023
Actual (reported)AUC0-t and Cmax of apixaban
AUC0-∞, Tmax and residual area of apixaban.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Eliquis 5 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 recordFormulated product
APIXABAN
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.
Eliquis 5 mg film-coated tablets
Named ingredient: apixaban
View registry recordAPIXABAN
Named ingredient: apixaban
View registry recordRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario De La Princesa
Madrid, 28006, Spain
Carmen Morillo Alonso
First Submitted
March 6, 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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