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Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs. 400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg BI 44847 as tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | BI 44847 suspension high dose, fasted |
|
| Treatment B | Experimental | BI 44847 tablet high dose, fasted |
|
| Treatment C | Experimental | BI 44847 tablet high dose, fed |
|
| Treatment D | Active Comparator | BI 44847 solution low dose, fasted |
|
| Treatment E | Experimental | BI 44847 tablet low dose, fasted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44847 solution, low dose | Drug |
| ||
| BI 44847 suspension, high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | up to 48 hours after drug administration | |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 48 hours after drug administration | |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 48 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| λz (terminal rate constant in plasma) | up to 48 hours after drug administration | |
| t1/2 (terminal half-life of the analyte in plasma) | up to 48 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| BI 44847 tablet, low dose | Drug |
|
| BI 44847 tablet, high dose | Drug |
|
| high fat breakfast | Other |
|
| MRTpo (mean residence time of the analyte in the body after po administration) |
| up to 48 hours after drug administration |
| CL/F (total clearance of the analyte in the plasma after extravascular administration) | up to 48 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 48 hours after drug administration |
| Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) | up to 48 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 48 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 48 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 48 hours after drug administration |
| tmax (time from dosing to maximum concentration) | up to 48 hours after drug administration |
| Number of patients with clinically relevant changes in vital signs | up to 3 days after last drug administration |
| Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG) | up to 3 days after last drug administration |
| Number of patients with adverse events | up to 3 days after last drug administration |
| Assessment of tolerability by investigator on a 4-point scale | day 3 |