Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Riociguat immediate release of · 1 trial · 1 indication
Marker of bone resorption
Area under the plasma concentration vs time curve (AUC) from zero to 7 hours after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)
AUC(0-7) at steady state
Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)
Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)
| Arm | Type | Description |
|---|---|---|
| Riociguat | ACTIVE_COMPARATOR | Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
| Placebo | PLACEBO_COMPARATOR | Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
| Name | Type | Description |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg | DRUG | Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days. |
| Placebo | DRUG | Placebo administered as a single tablet, thrice daily, over 14 days. |
Inclusion Criteria: * Healthy male white subjects * 18 to 45 years of age * BMI between 18 and 28 kg/m2 * Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period Exclusion Criteria: * Relevant deviation from the normal range i...