SYFf9a3044483b64ee4b1d869841d261308Registry ID: 2022-502420-51-00|UnknownPhase 1Results
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interventional
N/A
1 country
1
To assess the bioequivalence of an oral test preparation containing 50 mg dimenhydrinate per sachet Dimenhydrinate 50 mg Coated Granules when administered without water (Test 1 IMP) and Dimenhydrinate 50 mg Coated Granules when administered with 200 mL water (Test 2 IMP) as compared to two market standards Vomex A 50 mg Lösung zum Einnehmen im Beutel (Reference 1 IMP) and Biodramina 50 mg Comprimidos (Reference 2 IMP) under fasting conditions in four different periods, at least 7 days apart.
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 28, 2023
Actual (reported)AUC(0-t) and Cmax of diphenhydramine
tmax of diphenhydramine
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Vomex A 50 mg Lösung zum Einnehmen im Beutel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordFormulated product
Biodramina 50 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.
Vomex A 50 mg Lösung zum Einnehmen im Beutel
Named ingredient: Dimenhydrinate
View registry recordBiodramina 50 mg Comprimidos
Named ingredient: Dimenhydrinate
View registry recordBed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
Sofia, 1202, Bulgaria
Sacha Arsova; MD, PhD
Dr. Benjamin Schwenk
First Submitted
June 28, 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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