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The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 691751 after high fat breakfast | Experimental | single dose BI 691751 after a standardised high fat breakfast |
|
| BI 691751 fasted | Active Comparator | single dose BI 691751 in fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 691751 fasted | Drug | single dose BI 691751 in fasted state |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz) | up to 480 hours | |
| Maximum measured concentration of the analyte in plasma and whole blood (Cmax) | up to 480 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf) | up to 480 hours |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1334.28.01001 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States |
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| BI 691751 after high fat breakfast |
| Drug |
single dose BI 691751 after a standardised high fat breakfast |
|