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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520813-29-00 | EU Trial (CTIS) Number | ||
| U1111-1313-4642 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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This trial is conducted to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence A | Experimental | R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water |
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| Treatment sequence B | Experimental | T - test treatment: Empagliflozin dispersed in water and mixed with food, administered to subjects in fasting state with water R - reference treatment: Empagliflozin tablet, administered to subjects in fasting state with water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
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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 3 days | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 3 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 3 days |
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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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