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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-DK-AH 269 CL intravenous | Active Comparator |
| |
| [14C]-DK-AH 269 CL oral | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-DK-AH 269 CL, solution for infusion | Drug |
| ||
| [14C]-DK-AH 269 CL, drinking solution |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analytes in plasma (Cmax) | Up to 96 hours after start of treatment | |
| Area under the concentration-time curve of the analytes in plasma (AUC) | Up to 96 hours after start of treatment | |
| Time from dosing to the maximum concentration of the analytes in plasma (tmax) | Up to 96 hours after start of treatment | |
| Terminal rate constant of the analytes in plasma (λz) | Up to 96 hours after start of treatment | |
| Terminal half-life of the analytes in plasma (t1/2) | Up to 96 hours after start of treatment | |
| Mean residence time of the analytes in the body after intravenous administration (MRT) | Up to 96 hours after start of treatment | |
| Mean residence time of the analytes in the body after oral administration (MRTpo) | Up to 96 hours after start of treatment | |
| Apparent clearance of the analytes in plasma following extravascular administration (CL/F) | Up to 96 hours after start of treatment | |
| Total clearance of the analytes in plasma following intravascular administration (CL) | Up to 96 hours after start of treatment | |
| Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F) |
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Inclusion Criteria:
Exclusion Criteria:
Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the drugs under study or for the study:
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Drug |
|
| Up to 96 hours after start of treatment |
| Volume of distribution at steady state (Vss) | Up to 96 hours after start of treatment |
| Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz) | Up to 120 hours after start of treatment |
| Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz) | Up to 120 hours after start of treatment |
| Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz) | Up to 120 hours after start of treatment |
| Fraction of dose absorbed, based on radioactivity data (Fa) | Up to 96 hours after start of treatment |
| Absolute bioavailability of the analytes after oral administration (F) | Up to 96 hours after start of treatment |
| Ratio of CBlood cells/Cplasma [14C]-radioactivity | Up to 96 hours after start of treatment |
| Number of patients with clinically significant findings in vital signs | blood pressure, heart rate | up to 12 days after last drug administration |
| Number of patients with clinically significant findings in 12-lead ECG | up to 12 days after last drug administration |
| Number of patients with clinically significant findings in 2-lead ECG (telemetry) | up to 90 minutes after start of treatment |
| Clinically significant changes from baseline in physical examination | Pre-dose, and 12 days after last drug administration |
| Occurrence of visual phenomena | questionnaire | up to 120 hours after start of treatment |
| Number of patients with clinically significant findings in clinical laboratory tests | up to 12 days after last drug administration |