The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
BI 10773 and metformin single tablets, administered together in fasted state
BI 10773 / metformin fixed dose combination tablet in fasted state
1276.5.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV).
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empa: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV.
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Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Elimination Rate Constant in Plasma (λz)
Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Half-life in Plasma (T1/2)
Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Mean Residence Time in the Body After Oral Administration (MRTpo)
Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Time frame: Drug administration up to 7 days after last drug administration, up to 8 days