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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004929-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilaprisan + Itraconazole | Experimental | Vilaprisan (BAY1002670) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilaprisan (BAY1002670) | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve [AUC(0-11d)] after single oral dose of vilaprisan with and without ITZ. | up to 14 days | |
| Maximum plasma concentration (Cmax) after single oral dose of vilaprisan with and without ITZ. | up to 14 days |
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Inclusion Criteria:
Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration), in addition: in women < 65 years old, follicle stimulating hormone (FSH) > 40 IU/L
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds | West Yorkshire | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29330782 | Derived | Schultze-Mosgau MH, Hochel J, Prien O, Zimmermann T, Brooks A, Bush J, Rottmann A. Characterization of the Pharmacokinetics of Vilaprisan: Bioavailability, Excretion, Biotransformation, and Drug-Drug Interaction Potential. Clin Pharmacokinet. 2018 Aug;57(8):1001-1015. doi: 10.1007/s40262-017-0607-4. |
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| [14C] Vilaprisan | Drug | an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan |
|
| Itraconazole(ITZ) | Other | Itraconazole(ITZ) 200 mg as solution, once daily for 14 days |
|
| ID | Term |
|---|---|
| C586669 | vilaprisan |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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