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Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
Sponsor: Bayer
Summary
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form. About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.
Official title: A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-07-22
Completion Date
2027-02-22
Last Updated
2026-08-13
Healthy Volunteers
Yes
Interventions
Elinzanetant (BAY 3427080) treatment A
Elinzanetant treatment A is administered orally once daily.
Elinzanetant (BAY 3427080) treatment B
Elinzanetant treatment B is administered orally once daily.
Locations (1)
Altasciences
Mount Royal, Quebec, Canada