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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516256-18-00 | Registry Identifier | CTIS | |
| U1111-1312-4162 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate the effect of a single dose of BI 1291583 on the pharmacokinetics of a single dose of dabigatran, an efflux transporter P-glycoprotein (P-gp) substrate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T) | Experimental | R=reference treatment (period 1) T=test treatment (period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | dabigatran etexilate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to 4 days | |
| Maximum measured concentration of dabigatran in plasma (Cmax) | Up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 4 days |
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Inclusion Criteria :
Subjects will only be included in the trial if they meet the following criteria:
Exclusion Criteria :
Subjects will not be allowed to participate, if any of the following general criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
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| BI 1291583 | Drug | BI 1291583 |
|
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |