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The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | single dose BI 44847 administered to white subjects |
|
| Treatment B | Experimental | 100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects |
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| Treatment C | Experimental | single dose BI 44847 after a Japanese diet of 6 days administered to white subjects |
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| Treatment D | Experimental | single dose BI 44847 administered to asian subjects |
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| Treatment E | Experimental | single dose BI 44847 administered to african subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44847 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity) | up to 48 hours after drug administration | |
| AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h) | up to 48 hours after drug administration | |
| AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h) | up to 48 hours after drug administration | |
| Cmax (maximum concentration of the analyte in plasma) | up to 48 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (time from dosing to maximum concentration of the analyte in plasma) | up to 48 hours after drug administration | |
| λz (terminal rate constant in plasma after single dose | up to 48 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Acarbose |
| Drug |
|
|
| Japanese diet | Other |
|
| t1/2 (terminal half-life of the analyte in plasma after single dose) | up to 48 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after single dose) | up to 48 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose) | up to 48 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration) | up to 48 hours after drug administration |
| AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2) | up to 24 hours after drug administration |
| Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2) | up to 24 hours after drug administration |
| fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2) | up to 24 hours after drug administration |
| CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2) | up to 24 hours after drug administration |
| Amount of glucose excreted in urine | up to 24 hours after drug administration |
| Number of patients with adverse events | up to 48 hours after last administration of study drug |
| Number of patients with clinically relevant changes in laboratory tests | up to 48 hours after last administration of study drug |
| Number of patients with clinically relevant changes in Electrocardiogram (ECG) | up to 48 hours after last administration of study drug |
| Number of patients with clinically relevant changes in vital signs | up to 48 hours after last administration of study drug |
| Assessment of global tolerability by investigator on a 4-point scale | 48 hours after last administration of study drug |
| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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