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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003055-10 | EudraCT Number |
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This study should estimate the dose proportionality of BAY94-8862 IR tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY94-8862 (1.25mg) | Experimental | single dose BAY94-8862 IR tablet 1.25mg |
|
| BAY94-8862 (2.5mg) | Experimental | single dose BAY94-8862 IR tablet 2.5mg |
|
| BAY94-8862 (5mg) | Experimental | single dose BAY94-8862 IR tablet 5mg |
|
| BAY94-8862 (7.5mg) | Experimental | single dose BAY94-8862 IR tablet 7.5mg |
|
| BAY94-8862 (10mg) | Experimental | single dose BAY94-8862 IR tablet 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY94-8862 (1.25mg) | Drug |
| ||
| BAY94-8862 (2.5mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862 | Up to 48 h |
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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 |
|---|---|---|---|---|---|---|
| CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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| BAY94-8862 (5mg) | Drug |
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| BAY94-8862 (7.5mg) | Drug |
|
| BAY94-8862 (10mg) | Drug |
|