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The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), 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 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIF 1149 BS | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate) | up to 8 days after last drug administration | |
| Number of patients with clinically relevant changes in electrocardiogram (ECG) | up to 8 days after last drug administration | |
| Number of patients with clinically relevant changes in laboratory parameters | up to 8 days after last drug administration | |
| Number of patients with adverse events | up to 8 days after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug plasma concentration (Cmax) | up to 360 hours after drug administration | |
| Time to reach maximum drug concentration (tmax) | up to 360 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Total area under the plasma drug concentration-time curve (AUC) for several time points |
| up to 360 hours after drug administration |
| Terminal half-life (t1/2) | up to 360 hours after drug administration |
| Mean residence time (MRT) | up to 360 hours after drug administration |
| Total clearance after oral administration (CLtot/f) | up to 360 hours after drug administration |
| Amount of drug excreted in urine (Ae) | up to 360 hours after drug administration |
| Measurement of pharmacodynamic activity | Citric acid challenge | Screening, at least 15 days after first administration |
| Volume of Distribution during terminal phase after oral administration (Vz/F) | up to 360 hours after drug administration |
| Renal clearance in the time interval form 0 to x h (Clren0-xh) | up to 360 hours after drug administration |