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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004329-42 | EudraCT Number | EudraCT |
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To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 3 | Experimental | single dose of midazolam + BI drug |
|
| Treatment 4 | Experimental | single dose of probe drugs + BI drug |
|
| Treatment 5 | Experimental | single dose of digoxin + BI drug |
|
| Treatment 1 | Experimental | single doses of probe drugs |
|
| Treatment 2 | Experimental | single dose of digoxin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug |
| ||
| Warfarin |
| 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 midazolam and omeprazol after each dosing | up to 24 hours | |
| 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 digoxin after each dosing | up to 96 hours | |
| 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 warfarin after each dosing | up to 120 hours | |
| Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing | up to 24 hours | |
| Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing | up to 96 hours | |
| Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing | up to 120 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 |
|---|---|---|---|---|---|---|
| 1344.3.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D014859 | Warfarin |
| D008874 | Midazolam |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| BI 1181181 | Drug |
|
| Midazolam | Drug |
|
| Omeprazole | Drug |
|
| BI 1181181 | Drug |
|
| Midazolam | Drug |
|
| Midazolam | Drug |
|
| Warfarin | Drug |
|
| BI 1181181 | Drug |
|
| Digoxin | Drug |
|
| Digoxin | Drug |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |