Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004627-37 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | single dose of BI 187004 in fasted state |
|
| Treatment B | Experimental | single dose of BI 187004 |
|
| Treatment C | Experimental | single dose of BI 187004 in fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 187004 | Drug | single dose BI 187004 given as tablet in fed state |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004 | up to 17 days postdose | |
| Cmax (maximum measured concentration of the analyte in plasma) of BI 187004 | up to 17 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 17 days postdose |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1307.3.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI 187004 |
| Drug |
single dose BI 187004 given as tablet in fasted state |
|
| BI 187004 | Drug | single dose BI 187004 given as oral solution |
|