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The objective of the present study is to obtain information about the safety and tolerability of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIF 1149 BS - single rising doses | Experimental | BIIF 1149 BS oral drinking solution and a BIIF 1149 BS tablet |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIF 1149 BS - single rising doses | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 120 hours after drug administration | |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 120 hours after drug 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 120 hours after drug administration |
| Ae (Amount of parent drug excreted into urine) | up to 120 hours after drug administration |
| MRT (Mean residence time of the analyte in the body) | up to 120 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 120 hours after drug administration |
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 120 hours after drug administration |
| Ae (amount of analyte excreted into Urine) | up to 120 h after drug administration |
| CLren (renal clearance) | up to 120 h after drug administration |