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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521650-42-00 | Registry Identifier | CTIS | |
| U1111-1319-1746 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R -T1 -T2 | Experimental | R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed |
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| T1 - R - T2 | Experimental | R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vicadrostat / empagliflozin combination 1 | Drug | vicadrostat / empagliflozin combination 1 |
|
| 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 (AUC 0-tz) | Up to 4 days | |
| Maximum measured concentration of the analyte in plasma (C max) | Up to 4 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 (AUC 0-∞) | Up to 4 days |
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Inclusion Criteria :
Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)
Signed and dated written informed consent in accordance with Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
For female trial participants: Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | 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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three-way crossover
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| vicadrostat / empagliflozin 2 | Drug | vicadrostat / empagliflozin 2 |
|