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To investigate safety and pharmacokinetics of BI 224436 ZW
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 224436 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 224436 | Drug |
| ||
| Placebo to BI 224436 |
| Measure | Description | Time Frame |
|---|---|---|
| maximum measured concentration of the analyte in plasma | up to 72 hours | |
| area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 72 hours | |
| minimum observed concentration at 24 hours | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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|
| terminal half-life of the analyte in plasma | up to 72 hours |
| time from dosing to maximum measured concentration of the analyte in plasma | up to 72 hours |
| apparent clearance of the analyte in plasma | up to 72 hours |
| apparent volume of distribution during the terminal phase λz | up to 72 hours |
| apparent volume of distribution | up to 72 hours |
| mean residence time of the analyte in the body after single oral administration | up to 72 hours |
| terminal rate constant in plasma | up to 72 hours |
| the last measurable concentration in the concentration-time profile | up to 72 hours |
| the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity | up to 72 hours |
| the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation | up to 72 hours |
| amount of analyte that is eliminated in urine from the time point t0 to time point t4 | up to 4 hours |
| amount of analyte that is eliminated in urine from the time point t4 to time point t8 | from 4 to 8 hours |
| amount of analyte that is eliminated in urine from the time point t8 to time point t12 | from 8 to 12 hours |
| amount of analyte that is eliminated in urine from the time point t12 to time point t24 | from 12 to 24 hours |
| fraction of analyte eliminated in urine from time point t0 to time point t24 | up to 24 hours |
| renal clearance of the analyte from the time point t0 until the time point t24 | up to 24 hours |