This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI) between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using intravenous microtracer dose of \[14C\]vilaprisan.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
14
single oral doses of 4 mg tablet Vilaprisan, administered once without the comedication of ITZ (period 1) and once with the comedication of ITZ (period 2)
an intravenous microtracer dose of \[14C\]Vilaprisan administered together with the 1st single oral dose of Vilaprisan
Itraconazole(ITZ) 200 mg as solution, once daily for 14 days
Unnamed facility
Leeds, West Yorkshire, United Kingdom
Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ.
Time frame: up to 14 days
Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ.
Time frame: up to 14 days
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