(22424) Exploratory, randomized, non-blinded, crossover study to investigate the relative bioavailability of different elinzanetant soft gel capsules in healthy participants
interventional
N/A
1 country
1
To investigate the relative bioavailability of two soft gel capsule formulations versus the currently used Phase 3 formulation when administered as single oral dose under fasting conditions
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 24, 2023
Actual (reported)Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC)* after single dose under fasted condition *Area under the concentration vs. time curve from zero to last quantifiable concentration (AUC(0-tlast)) will be used as main parameter if AUC cannot be calculated reliably in all participants
Maximum observed concentration (Cmax) after single dose under fasted condition
Number of participants with treatment-emergent adverse events and severity of treatment-emergent adverse events
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Elinzanetant Bayer
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordFormulated product
BAY 3427080
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordFormulated product
Elinzanetant Bayer
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Elinzanetant Bayer
Named ingredient: elinzanetant
View registry recordBAY 3427080
Named ingredient: elinzanetant
View registry recordElinzanetant Bayer
Named ingredient: elinzanetant
View registry recordCRS Clinical Research Services Management GmbH
Wuppertal, 42113, Germany
Therapeutic Area Head
First Submitted
May 24, 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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