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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 intranasal 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 |
|---|---|---|
| Changes in nasal mucosa assessed by rhinoscopy | up to 2 hours after treatment | |
| Changes in nasal flow and resistance assessed by rhinomanometry | up to 2 hours after treatment | |
| Number of patients with adverse events | up to 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 12 hours after intranasal administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 12 hours after intranasal administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 12 hours after intranasal administration |
| MRT (Mean residence time of the analyte in the body) | up to 12 hours after intranasal administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 12 hours after intranasal administration |
| CL (systemic clearance) | up to 12 hours after intranasal administration |
| Vd (Volume of distribution) | up to 12 hours after intranasal administration |