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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005507-24 | EudraCT Number | EudraCT |
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The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 BI 1060469 low dose | Experimental | TF2 followed by iFF followed by TF1 |
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| 1 BI 1060469 high dose | Experimental | TF1 followed by TF2 followed by iFF |
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| 2 BI 1060469 high dose | Experimental | iFF followed by TF1 followed by TF2 |
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| 3 BI 1060469 high dose | Experimental | TF2 followed by iFF followed by TF1 |
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| 1 BI 1060469 low dose | Experimental | TF1 followed by TF2 followed by iFF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1060469, iFF, Test | Drug |
| ||
| BI 1060469, iFF, Test |
| 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) | up to 72 h | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 h |
| 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 72 h |
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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 |
|---|---|---|---|---|---|---|
| 1333.4.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| 2 BI 1060469 low dose | Experimental | iFF followed by TF1 followed by TF2 |
|
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| BI 1060469, TF1, Reference | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, iFF, Test | Drug |
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| BI 1060469, TF1, Reference | Drug |
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| BI 1060469, iFF, Test | Drug |
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| BI 1060469, iFF, Test | Drug |
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| BI 1060469, TF1, Reference | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, TF1, Reference | Drug |
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| BI 1060469, TF1, Reference | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, iFF, Test | Drug |
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| BI 1060469, TF2, Test | Drug |
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| BI 1060469, TF1, Reference | Drug |
|