Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Part I: Treatment A
Part I: Treatment B
Part II: Treatment C
AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 48 h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
Time frame: up to 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 48 h after drug administration
AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2)
Time frame: up to 48 h after drug administration
tmax (time from dosing to the maximum concentration of metformin in plasma)
Time frame: up to 48 h after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 48 h after drug administration
t1/2 (terminal half-life of metformin in plasma)
Time frame: up to 48 h after drug administration
MRTpo (mean residence time of metformin in the body after po administration)
Time frame: up to 48 h after drug administration
CL/F (apparent clearance of metformin in the plasma after extravascular administration)
Time frame: up to 48 h after drug administration
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Part II: Treatment D
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 h after drug administration
Number of patients with clinically relevant differences in physical examination
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in vital signs (BP (Blood pressure), PR (Pulse rate))
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in 12-lead ECG (electrocardiogram)
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with clinically relevant differences in clinical laboratory tests
Time frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration
Number of patients with adverse events
Time frame: within 2- 10 after last study drug administration
Assessment of tolerability by investigator on a 4 point scale
Time frame: within 2- 10 after last study drug administration