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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005166-18 | EudraCT Number |
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To investigate relative bioavailability of crushed tablets suspended in apple sauce or water
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY63-2521 with Non sparkling water | Experimental | Single dose of a whole 2.5 mg riociguat tablet (fasted) with 240 mL of non-sparkling water at room temperature |
|
| BAY63-2521 with applesauce | Experimental | Single dose of a crushed 2.5 mg riociguat tablet suspended in 50 mL applesauce, to be eaten with a spoon (fasted) |
|
| BAY63-2521 with water | Experimental | Single dose of a crushed 2.5 mg riociguat tablet suspended in a glass with 25 mL water, to be drunk and flushed twice with 25 mL water in the same glass (fasted) |
|
| BAY63-2521 after breakfast | Experimental | Single dose of a whole 2.5 mg riociguat tablet taken within 5 minutes after the last bite of a continental breakfast (fed) with 240 mL of non-sparkling water at room temperature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat(Adempas,BAY63-2521) | Drug | Single dose of a whole 2.5 mg riociguat tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC) | Multiple time points up to day 3 | |
| Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax) | Multiple time ponits up to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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