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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522432-14 | Registry Identifier | CTIS | |
| U1111-1322-9764 | Registry Identifier | WHO Registry |
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The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 764198 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference - Treatment (R-T) | Experimental | This arm starts with the reference treatment (R), metformin hydrochloride, followed by a washout period, and then the test treatment (T), metformin hydrochloride and BI 764198. |
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| Treatment - Reference (T-R) | Experimental | This arm starts with the test treatment (T), metformin hydrochloride and BI 764198, followed by a washout period, and then the reference treatment (R), metformin hydrochloride. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin hydrochloride | Drug | Metformin hydrochloride |
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| Measure | Description | Time Frame |
|---|---|---|
| Metformin: Area under the concentration-time (AUC) curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss) | Up to 5 days | |
| Metformin: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Metformin: Renal clearance of the analyte from plasma at steady state (CL R,ss) | Up to 5 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| BI 764198 | Drug | BI 764198 |
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