Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
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)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
λz (terminal rate constant in plasma)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
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CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
Glucose excretion in urine
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
Creatinine excretion in urine
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose
Abnormal findings in physical examination
Time frame: Baseline and within 14 days after last trial procedure
Changes from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline and within 14 days after last trial procedure
Changes from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and within 14 days after last trial procedure
Changes from baseline in routine laboratory tests
Time frame: Baseline and within 14 days after last trial procedure
Incidence of adverse events
Time frame: Up to 15 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Within 14 days after last trial procedure