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Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental |
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| Sequence CAB | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug |
| ||
| Linagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„) | up to day 8 | |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„) | up to day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state) | up to day 8 | |
| Urine glucose excretion (UGE) | Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit |
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Inclusion Criteria:
Healthy male volunteers according to the following criteria:
Age 18 to 50 years (inclusive)
BMI 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Exclusion Criteria:
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition | 2 hours and 24 hours after last administration of study drug |
| Changes from baseline in physical examination | Baseline and within 5 days after last study drug administration |
| Changes from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 1 and within 5 days after last study drug administration |
| Changes from baseline in 12-lead ECG (electrocardiogram) | Baseline and within 5 days after last study drug administration |
| Changes from baseline clinical laboratory tests | Baseline, day 1 and within 5 days after last study drug administration |
| Incidence of adverse events | Up to 56 days |
| Assessment of tolerability by investigator on a 4-point scale | Within 5 days after last study drug administration |
| D011799 | Quinazolines |