Relative bioavailability of BI 10773 given alone and together with verapamil
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
1245.43.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Time From 0 to Maximum Plasma Concentration (Tmax)
Time from last dosing to the maximum plasma concentration
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Terminal Elimination Rate Constant (λz)
Terminal elimination rate constant in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Terminal Half-life in Plasma (t1/2)
Terminal half-life of empagliflozin in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation.
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Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Mean Residence Time in the Body After Administration (MRTpo)
Mean residence time of empagliflozin (empa) in the body after oral administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Apparent Clearance in Plasma After Extravascular Administration (CL/F)
Apparent clearance of empagliflozin (empa) in plasma after extravascular administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)
Apparent volume of distribution during the terminal phase following an extravascular dose. Note: The numbers provide below for standard deviation are of Coefficient of Variation.
Time frame: 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).
Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.
Time frame: Day1 to Day 11
Assessment of Tolerability by Investigator
Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.
Time frame: Within Day 15 to Day 25