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The objective was to investigate a possible drug-drug interaction between BI 10773 and metformin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and metformin were determined when both drugs were given in combination compared with BI 10773 or metformin 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 |
| ||
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 7 days | |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose) of BI 10773 | up to 7 days | |
| C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose) of metformin |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| up to 7 days |
| λz,ss (terminal half-life of the analyte in plasma) | up to 7 days |
| t½,ss (terminal half-life of the analyte in plasma at steady state) | up to 7 days |
| tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 7 days |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) | up to 7 days |
| CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) | up to 7 days |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) | up to 7 days |
| Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) | 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing |
| fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) | 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing |
| CLR,ss (renal clearance of the analyte at steady state) of BI 10773 and metformin | 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing |
| Urinary glucose excretion (UGE) | 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing |
| Number of patients with abnormal findings in physical examination | Baseline and within 3-14 days after last study drug administration |
| Number of patients with clinically significant changes in vital signs (Blood Pressure, Pulse Rate) | Baseline, day 1 and within 3-14 days after last study drug administration |
| Number of patients with abnormal findings in 12-lead ECG (electrocardiogram) | Baseline and within 3-14 days after last study drug administration |
| Number of patients with abnormal changes in clinical laboratory tests | Baseline, day 1, 4, 5 and within 3-14 days after last study drug administration |
| Number of patients with adverse events | up to 40 days |
| Assessment of tolerability by investigator on a 4-point scale | Within 3-14 days after last study drug administration |