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The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIF 1149 BS - single rising dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIF 1149 BS - single rising dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 55 days | |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last blood sample | |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate) | up to 8 days after last blood sample |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG) | up to 8 days after last blood sample | |
| Cmax (Maximum concentration of the analyte in plasma) | up to 360 hours after last drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Tmax (Time to maximum observed concentration of the analyte in plasma) | up to 360 hours after last drug administration |
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 360 hours after last drug administration |
| Ae (Urinary excretion of parent drug) | up to 120 hours after last drug administration |
| Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | after 24 hours of drug administration on day 9 |
| MRT (Mean residence time of the analyte in the body) | up to 360 hours after last drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 360 hours after last drug administration |
| Percent peak-trough fluctuation | up to 360 hours after last drug administration |
| RA (AUC) Accumulation factor based on AUC-data | up to 360 hours after last drug administration |
| RA (Ae) Accumulation factor based on Ae-data | up to 120 hours after last drug administration |
| RA (Cmax) Accumulation factor based on Cmax -data | up to 360 hours after drug administration on day 9 |
| Cav (Average plasma concentration in a steady state interval) | 24 hours after drug administration of day 9 |