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The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Active Comparator |
| |
| Pioglitazone + BI 10773 low | Experimental |
| |
| Pioglitazone + BI 10773 medium | Experimental |
| |
| Pioglitazone + BI 10773 high | Experimental |
| |
| Pioglitazone low + BI 10773 medium | Experimental |
| |
| Pioglitazone + BI 10773 1 hour after Pioglitazone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug |
|
| 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) | Before each dosing, up to 10 days | |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | Before each dosing, up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose) | Before each dosing, up to 10 days | |
| λz (terminal elimination rate constant of the analyte in plasma) | Before each dosing, up to 10 days |
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Inclusion Criteria:
Healthy male subjects according to the following criteria:
medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests
Age 18 to 55 years (incl.)
BMI 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practise (GCP) and the local legislation
Exclusion Criteria:
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| Pioglitazone - low dose | Drug |
|
| BI 10773 - low dose | Drug |
|
| BI 10773 - medium dose | Drug |
|
| BI 10773 - high dose | Drug |
|
| t½ (terminal half-life of the analyte in plasma) | Before each dosing, up to 10 days |
| tmax (time from last dosing to maximum measured concentration of the analyte in plasma) | Before each dosing, up to 10 days |
| MRTpo (mean residence time of the analyte in the body at steady state after oral administration) | Before each dosing, up to 10 days |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Before each dosing, up to 10 days |
| Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration) | Before each dosing, up to 10 days |
| Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 ) | Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) |
| fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2) | Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) |
| CLR (renal clearance of the analyte in plasma afer extravascular administration) | Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) |
| Cmax (maximum concentration of the analyte in plasma) | Before each dosing, up to 10 days |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration) | Before each dosing, up to 10 days |
| AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration within the first dosing interval) | Before each dosing, up to 10 days |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | Before each dosing, up to 10 days |
| Metabolite to parent ratio | Before each dosing, up to 10 days |
| Number of patients with abnormal findings in physical examination | up to 30 days after drug administration |
| Number of patients with abnormal changes in laboratory parameters | up to 30 days after drug administration |
| Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) | up to 30 days after drug administration |
| Number of patients with clinically significant changes in vital signs | up to 30 days after drug administration |
| Assessment of tolerability by investigator on a 4-point scale | up to 10 days |
| Number of patients with adverse events | up to 51 days |
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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