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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000258-23 | EudraCT Number | EudraCT |
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The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 144807 PfoS Treatment A | Experimental | intermediate dose of BI 144807 |
|
| BI 144807 PfoS Treatment C | Experimental | high dose of BI 144807 |
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| BI 144807 Tab Treatment B | Experimental | intermediate dose of BI 144807 |
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| BI 144807 Tab Treatment D | Experimental | high dose of BI 144807 |
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| BI 144807 Tab Treatment E | Experimental | intermediate dose of BI 144807, fasted |
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| BI 144807 Tab Treatment F | Experimental | intermediate dose of BI 144807, fed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 144807 high dose | Drug | oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | 48 hours | |
| Maximum measured concentration of the analyte in plasma (Cmax) | 48 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 (AUC0-inf) | 48 hours |
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Inclusion criteria:
- Healthy male subjects
Exclusion criteria:
- Any relevant deviation from healthy condition
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1313.9.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| BI 144807 Tab Treatment G | Experimental | intermediate dose of BI 144807, fasted |
|
| BI 144807 intermediate dose |
| Drug |
tablet |
|
| BI 144807 intermediate dose | Drug | tablet |
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| BI 144807 intermediate dose | Drug | tablet |
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| BI 144807 intermediate dose | Drug | tablet |
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| BI 144807 intermediate dose | Drug | oral solution |
|
| BI 144807 high dose | Drug | tablet |
|