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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521419-37-00 | Registry Identifier | CTIS (EU) | |
| U1111-1319-7116 | 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 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 456906 formulation A then BI 456906 formulation B2 | Experimental | BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment |
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| BI 456906 formulation B2 then BI 456906 formulation A | Experimental | BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 456906 formulation A | Combination Product | BI 456906 formulation A |
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| 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) | Up to 22 days. | |
| Cmax (maximum measured concentration of the analyte in plasma) | Up to 22 days. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | Up to 22 days. |
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Inclusion Criteria
Trial participants will only be included in the trial if they meet the following criteria:
Exclusion Criteria :
Participants will not be allowed to participate, if any of the following general criteria apply:
Any finding in the medical examination (BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular:
Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | 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 B2 | Drug | BI 456906 formulation B2 |
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