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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004628-13 | EudraCT Number | EudraCT |
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To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | multiple doses BI 187004 |
|
| Treatment B | Experimental | multiple doses BI 187004 + multiple doses metformin |
|
| Treatment C | Experimental | multiple doses metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | multiple doses metformin given as tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 | up to 24 hours postdose | |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for metformin | up to 12 hours postdose | |
| Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004 | up to 24 hours postdose | |
| Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for metformin | up to 12 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| 1307.7.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| BI 187004 |
| Drug |
multiple doses BI 187004 given as tablets |
|
| BI 187004 | Drug | multiple doses BI 187004 given as tablets |
|
| metformin | Drug | multiple doses metformin given as tablet |
|
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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