SYFd56d214e59c947139f4b57c9ed3ba237Registry ID: 2023-506416-41-00|UnknownPhase 1Results
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interventional
N/A
1 country
1
Compare the bioavailability of Tecnimede’s Empagliflozin 25 mg film-coated tablets (Test product) with Jardiance® 25 mg film-coated tablets (Reference product).
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.
June 26, 2023
Actual (reported)Cmax and AUC0-t of Empagliflozin.
tmax, t1/2, AUC0-∞, %AUCextrap, λz of Empagliflozin.
Occurrence of treatment-emergent adverse events (TEAEs), 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
Empagliflozin 25 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
Jardiance 25 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.
Empagliflozin 25 mg film-coated tablets
Named ingredient: empagliflozin
View registry recordJardiance 25 mg film-coated tablets
Named ingredient: empagliflozin
View registry recordBlueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, 4250-449, Portugal
Rita Neves
First Submitted
June 26, 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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