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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520656-29-00 | Registry Identifier | CTIS | |
| U1111-1317-7517 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The objective of this trial is to assess the effect of BI 3000202 on the pharmacokinetics of rosuvastatin and digoxin given as a cocktail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail (Reference) then BI 3000202-Cocktail (Test) | Experimental | Cocktail consisting of rosuvastatin and digoxin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3000202 | Drug | BI 3000202 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 7 | |
| Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 7 | |
| Maximum measured concentration of rosuvastatin in plasma (Cmax) | Up to Day 7 | |
| Maximum measured concentration of digoxin in plasma (Cmax) | Up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 7 | |
| Area under the concentration-time curve of digoxin 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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Participants cross over from reference treatment (R) to test treatment (T) (two periods, fixed sequence).
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| Rosuvastatin |
| Drug |
Rosuvastatin |
|
|
| Digoxin | Drug | Digoxin |
|
|
| Up to Day 7 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |