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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518103-21-00 | Registry Identifier | CTIS | |
| U1111-1313-3279 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence A: R1-R2-T | Experimental | Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together |
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| Treatment sequence B: R2-T-R1 | Experimental | Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together |
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| Treatment sequence C: T-R1-R2 | Experimental | Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicadrostat | Drug | Vicadrostat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) | |
| Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) | |
| Maximum measured concentration of vicadrostat in plasma (Cmax) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) | |
| Maximum measured concentration of empagliflozin in plasma (Cmax) | Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of vicadrostat in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz ) | Reference 1 (Days 1, 2 and 3), Test (Days 1, 2 and 3) | |
| Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) |
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Inclusion Criteria :
Exclusion Criteria :
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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 |
|---|---|
| C570240 | empagliflozin |
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| Jardiance® | Drug | Jardiance® |
|
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| Reference 2 (Days 1, 2, 3 and 4), Test (Days 1, 2, 3 and 4) |