The objective was to assess the relative bioavailability of a pilot scale linagliptin 2.5 mg / metformin 1000 mg fixed dose combination (FDC) tablet in comparison with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
AUC0-72 h (area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h)
Time frame: up to 72 hours after administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 168 hours after administration
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 to infinity)
Time frame: up to 168 h after administration
tmax (time from dosing to maximum concentration of the analyte in plasma)
Time frame: up to 168 hours after administration
λz (terminal elimination rate constant of the analyte in plasma)
Time frame: up to 168 hours after administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 168 hours after administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 168 hours after administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 168 hours after administration
Vz/F (apparent volume of distribution during the terminal phase λz of the analyte following an extravascular dose)
Time frame: up to 168 hours after administration
Number of patients with adverse events
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Time frame: up to 11 weeks
Assessment of tolerability on a 4-point scale by investigator
Time frame: 14 days after last study drug administration
AUC0-24 h (area under the concentration-time curve of BI 1356 and metformin in plasma over the time interval from 0 to the 24 h)
Time frame: up to 24 h after administration
AUC0-tz (area under the concentration-time curve of BI 1356 and metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 168 h after administration
AUC0-∞ (area under the concentration time curve of BI 1356 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 168 h after administration