| |
Study part I |
Study part II |
| |
Glucophage 1000 mg Merck (n=28) |
Glucophage 1000 mg BMS (n=28) |
Glucophage 500 mg Merck (n=28) |
Glucophage 500 mg BMS (n=28) |
| AUC0-inf (ng•h/mL) |
9360 (21.3) |
9620 (20.0) |
5770 (24.4) |
5670 (27.5) |
| AUC0-tz (ng•h/mL) |
9180 (21.7) |
9410 (21.6) |
5650 (25.1) |
5550 (27.8) |
| Cmax(ng/mL) |
1560 (27.4) |
1580 (25.3) |
955 (29.9) |
942 (28.6) |
| tmax(h)* |
2.50 (0.52−3.50) |
2.50 (0.98−4.03) |
2.50 (1.00−4.00) |
2.50 (1.50−4.00) |
| CL/F(mL/min) |
1780 (21.3) |
1730 (20.0) |
1440 (24.4) |
1470 (27.5) |
| Vz/F (L) |
1120 (55.0) |
1050 (71.5) |
862 (62.0) |
797 (59.1) |
| t1/2(h) |
7.29 (49.5) |
7.01 (60.0) |
6.89 (54.4) |
6.26 (51.8) |
*Median and range are given
AUC0-inf, area under the concentration-time curve of the analyte in plasma from 0 to infinity; AUC0-tz, area under the concentration-time curve of the analyte in plasma
from 0 to the last measurable concentration in plasma; Cmax, maximum measured concentration of the analyte in plasma; tmax, time from dosing to the maximum measured
concentration of the analyte in plasma; CL/F, apparent clearance of the analyte in plasma following extravascular administration; Vz/F, apparent volume of distribution during
the terminal phase λz following an extravascular dose; t½, terminal half-life of the analyte in plasma; gCV geometric coefficient of variation |
