Study to investigate the effect of food on the relative bioavailability of a 2.5 mg linagliptin+1000 mg metformin fixed dose combination (FDC) tablet
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
Time frame: up to 72 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 h extrapolated to infinity)
Time frame: up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 h extrapolated to infinity)
Time frame: up to 72 hours after drug administration
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: up to 72 hours after drug administration
AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
λz (terminal elimination rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
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MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Time frame: up to 7 days after drug administration
Number of subjects with clinically significant findings in ECG
Time frame: up to 7 days after drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 7 days after drug administration
Number of subjects with adverse events
Time frame: up to 7 days after drug administration
Assessment of tolerability by the investigator on a 4-point scale
Time frame: up to 7 days after drug administration