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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521279-30-00 | Registry Identifier | CTIS | |
| U1111-1320-6353 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate the effect of carbamazepine on pharmacokinetics of nerandomilast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerandomilast alone followed by nerandomilast + carbamazepine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nerandomilast | Drug | nerandomilast |
|
| 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 30 days | |
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Plasma Concentration Curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) | Up to 30 days |
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Inclusion Criteria :
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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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| carbamazepine | Drug | carbamazepine |
|