Randomised, crossover bioequivalence clinical trial of pregabalin 300 mg tablets versus pregabalin 300 mg hard capsules, 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 pregabalin compared to the commercial formulation 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.
July 28, 2022
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
Lyrica 300 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Pregabalina Normon 300 mg comprimidos
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.
Lyrica 300 mg hard capsules
Named ingredient: Pregabalin
View registry recordPregabalina Normon 300 mg comprimidos
Named ingredient: Pregabalin
View registry recordHospital Universitario De La Princesa
Madrid, 28006, Spain
Carlos Govantes (R&D Director)
First Submitted
July 28, 2022
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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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