Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 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 until 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 last drug administration
Number of subjects with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: up to 7 days after last drug administration
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 7 days after last drug administration
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 7 days after last drug administration