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The objective of this trial was to evaluate the relative oral bioavailability and pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and tolerability of the substances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | BI 44370 TA drinking solution 100 mg fasted |
|
| Treatment B | Experimental | BI 44370 TA drinking solution 100 mg fed |
|
| Treatment C | Experimental | BI 44370 TA drinking solution 200 mg fasted |
|
| Treatment D | Experimental | BI 44370 TA drinking solution 200 mg fed |
|
| Treatment E | Experimental | 100 mg BI 44370 BS as two tablets 50 mg fasted |
|
| Treatment F | Experimental | 100 mg BI 44370 BS as two tablets 50 mg fed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44370 powder for oral solution | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | up to 24 hours after drug administration | |
| AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration) | up to 2 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 24 hours after drug administration | |
| tmax (time from dosing to maximum measured concentration) | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 24 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) |
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Inclusion Criteria:
Exclusion Criteria:
For Male Subjects:
For Female Subjects:
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|
| BI 44370 tablet |
| Drug |
|
| high fat breakfast | Other |
|
| up to 24 hours after drug administration |
| AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) | up to 24 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 24 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 24 hours after drug administration |
| MRTp.o. (mean residence time of the analyte in the body after p.o. administration) | up to 24 hours after drug administration |
| CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) | up to 24 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 24 hours after drug administration |
| Number of patients with clinically relevant findings in vital signs (blood pressure and pulse rate) | up to 11 days |
| Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram) | up to 11 days |
| Number of patients with clinically relevant laboratory findings | up to 11 days |
| Number of patients with adverse events | up to 34 days |
| Assessment of tolerability by investigator on a 4-point scale | within 10 days after administration of study drug |
| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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