Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1002670_Vilaprisan · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Treatment A (Period 1): a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam Treatment B (Period 2): 600 mg Rifampicin once daily (qd) for 7 days followed by administration of a single oral dose of 4 mg Vilaprisan and 1 mg Midazolam followed by 600 mg Rifampicin 12 hours after Vilaprisan and Midazolam administration and continued dosing of 600 mg Rifampicin once daily for 3 days |
| Name | Type | Description |
|---|---|---|
| Rifampicin | DRUG | 11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin. |
| Midazolam | DRUG | 2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam |
| BAY1002670_Vilaprisan | DRUG | 2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan |
Inclusion Criteria: * Healthy female postmenopausal subjects * Age: 45 to 65 years (inclusive) * Body mass index (BMI) : ≥20 and ≤32 kg/m² * Race: White Exclusion Criteria: * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinica...