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The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing doses in healthy male and female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBN 4096 BS - in single rising doses | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBN 4096 BS - in single rising doses | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 2 months | |
| Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate, respiratory rate) | up to 8 days after last study day | |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last study day | |
| Number of subjects with clinically relevant changes in venous-occlusion plethysmography | up to 8 hours after drug administration | |
| Number of subjects with clinically significant changes in ECG (Electrocardiogram) | up to 8 days after last study day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 24 hours after drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 24 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| t½ (Terminal half-life of the analyte in plasma) | up to 24 hours after drug administration |
| MRT (Mean residence time of the analyte in the body) | up to 24 hours after drug administration |
| CL (Total clearance of the analyte in plasma following extravascular administration) | up to 24 hours after drug administration |
| Vz (Apparent volume of distribution during the terminal elimination phase) | up to 24 hours after drug administration |
| Vss (Volume of distribution at steady state) | up to 24 hours after drug administration |
| Percentage of urinary excretion of BIBN 4096 BS | up to 24 hours after drug administration |