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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516529-30-00 | Registry Identifier | CTIS | |
| U1111-1310-7283 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence R-T2-T1 | Experimental | T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A |
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| Treatment sequence T1-R-T2 | Experimental |
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| Treatment sequence T2-T1-R | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 456906 - Formulation A | Combination Product | Formulation A |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to 22 days | |
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 22 days |
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Inclusion Criteria:
Further inclusion criteria apply.
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach/Riß | 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| BI 456906 - Formulation B | Drug | Formulation B |
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| BI 456906 - Formulation C | Drug | Formulation C |
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