Randomised, crossover bioequivalence clinical trial of hydrochlorothiazide 25 mg tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
interventional
N/A
1 country
1
To evaluate the bioequivalence of the test formulation of hydrochlorothiazide compared to the commercial formulations taken as reference 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.
May 31, 2023
Actual (reported)AUC0-t
Cmax
AUC0-∞
Tmax
Residual area
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Esidrex 25 mg comprimidos
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
Hidroclorotiazida Normon 25 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.
Esidrex 25 mg comprimidos
Named ingredient: Hydrochlorothiazide
View registry recordHidroclorotiazida Normon 25 mg comprimidos
Named ingredient: Hydrochlorothiazide
View registry recordHospital Universitario De La Princesa
Madrid, 28006, Spain
Carlos Govantes (R&D Director)
First Submitted
May 31, 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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