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The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773 and glimepiride were determined when both drugs were given in combination compared to multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride 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 |
| ||
| Glimepiride |
| 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) of BI 10773 | up to 5 days | |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773 | up to 5 days | |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of glimepiride | up to 4 days | |
| Cmax (maximum measured concentration of the analyte in plasma) of glimepiride | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) of glimepiride | up to 4 days | |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| C057619 | glimepiride |
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|
| up to 4 days |
| λz (terminal rate constant in plasma) of glimepiride | up to 4 days |
| t½ (terminal half-life of the analyte in plasma) of glimepiride | up to 4 days |
| MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride | up to 4 days |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) of glimepiride | up to 4 days |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of glimepiride | up to 4 days |
| tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773 | up to 5 days |
| Aet1-t2 (amount of analyte eliminated in urine over the time interval from t1 to t2) of glimepiride | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 |
| fet1-t2 (fraction of analyte excreted unchanged in urine over the time interval from t1 to t2) of glimepiride | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 |
| CLR (renal clearance of the analyte) of glimepiride | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 |
| λz,ss (terminal rate constant of analyte in plasma at steady-state) of BI 10773 | up to 5 days |
| t½,ss (terminal half-life of analyte in plasma at steady-state) of BI 10773 | up to 5 days |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773 | up to 5 days |
| CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773 | up to 5 days |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 10773 | up to 5 days |
| Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) of BI 10773 | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 |
| fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) of BI 10773 | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 |
| CLR,ss (renal clearance of the analyte at steady state) of BI 10773 | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 |
| UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h) | 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on days 1 and 5 |
| Number of patients with abnormal findings in physical examination | Baseline and within 3-14 days after last glimepiride 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 glimepiride administration |
| Number of patients with abnormal findings in 12-lead ECG (electrocardiogram) | Baseline, day 1 and within 3-14 days after last glimepiride administration |
| Number of patients with abnormal findings in clinical laboratory tests | Baseline, day 1,4 and within 3-14 days after last glimepiride administration |
| Number of patients with adverse events | Up to 34 days |
| Assessment of tolerability by investigator on a 4-point scale | Within 3-14 days after last glimepiride administration |
| Number of patients with abnormal findings in glucose bedside tests | Pre-dose and 1, 2, 4, 7, 10, 14, 24 hours after glimepiride administration on day 1 |