RANDOMISED, CROSSOVER BIOEQUIVALENCE CLINICAL TRIAL OF LINAGLIPTIN 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 linagliptin 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.
June 15, 2023
Actual (reported)AUC0-72 and Cmax of linagliptin.
AUC0-∞, Tmax and residual area of linagliptin.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Trajenta 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
Linagliptina 5 mg Comprimido recubierto
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Trajenta 5 mg film-coated tablets
Named ingredient: Linagliptin
View registry recordLinagliptina 5 mg Comprimido recubierto
Named ingredient: Linagliptin
View registry recordUnidad de Ensayos Clínicos Hospital Universitario de la Princesa
Madrid, 28006, Spain
Carmen Morillo Alonso
First Submitted
June 15, 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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Source retrieved:
The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers
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