Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
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
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours
AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours
AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours
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
%AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation)
Time frame: up to 72 hours
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
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours
λz (terminal elimination rate constant in plasma)
Time frame: up to 72 hours
t1/2 (terminal half-life of the analyte in plasma)
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Time frame: up to 72 hours
MRTpo (mean residence time of the analyte in the body after peroral administration)
Time frame: up to 72 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 72 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours
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 12-lead electrocardiogram (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 investigator on a 4-point scale
Time frame: up to 7 days after drug administration