Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005030-38 | 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 assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repaglinide + Bupropion + BI 187004 | Experimental | repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide | Drug | single dose on day 1 of visits 2 and 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point | up to 48 h post dose | |
| Maximum measured concentration of repaglinide in plasma | up to 48 h post dose | |
| Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point | up to 119 h post dose | |
| Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point | up to 119 h post dose | |
| Maximum measured concentration of total bupropion in plasma | up to 119 h post dose | |
| Maximum measured concentration of S-bupropion in plasma | up to 119 h post dose |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Further exclusion criteria may apply.
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 |
|---|---|---|---|---|---|---|
| 1307.20.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI 187004 tablet |
| Drug |
multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3 |
|
| bupropion extended release tablet | Drug | single dose on day 3 of visits 2 and 3 |
|
| ID | Term |
|---|---|
| C072379 | repaglinide |
Not provided
Not provided
Not provided