Randomised, crossover bioequivalence clinical trial of apixabán 5 mg film coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
interventional
N/A
1 country
1
To evaluate the relative bioavailability of the test formulation of apixaban film-coated 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
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2023
Actual (reported)AUC0-t
Cmax
AUC0-∞
Tmax
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
Apixabán Normon 5 mg comprimidos recubiertos con película
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 recordApixabán Normon 5 mg comprimidos recubiertos con película
Named ingredient: apixaban
View registry recordHospital Universitario De La Princesa
Madrid, 28006, Spain
Carlos Govantes (R&D Director)
First Submitted
February 27, 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:
Contact the study team to confirm eligibility.