Table 2.
Geometric mean (GCV%) for metformin plasma PK parameters for the test and reference products under fasted and fed conditions (PK analysis set).
| Parameter | Geometric mean (GCV%) | |||
|---|---|---|---|---|
| Test product, fasted [n = 26] | Reference product, fasted [n = 26] | Test product, fed [n = 18] | Reference product, fed [n = 18] | |
| Cmax [ng/mL] | 1110 (30.1) | 1110 (22.7) | 711 (22.4) | 700 (18.6) |
| AUCt [ng·h/mL] | 6260 (22.4) | 6280 (16.3) | 4950 (25.6) | 5020 (23.3) |
| AUC∞ [ng·h/mL] | 6520 (20.2)b | 6410 (16.0) | 5070 (25.0) | 5160 (21.2) |
| tmax [h]a | 2.00 (1.00, 4.00) | 2.00 (1.00, 4.00) | 2.75 (1.50, 5.00) | 2.75 (1.00, 4.00) |
| t½ [h] | 4.38 (40.5)b | 4.90 (47.4) | 4.23 (45.6) | 4.16 (67.3) |
| CL/f [L/h] | 76.7 (20.2)b | 78.0 (16.0) | 98.6 (25.0) | 96.8 (21.2) |
| Vz/f [L] | 485 (46.6)b | 551 (52.5) | 602 (34.3) | 581 (73.1) |
aData are expressed as median (minimum, maximum)
bn = 25
AUC∞ area under the plasma concentration-time curve from time zero to infinity, AUCt area under the plasma concentration-time curve from time zero to the last sampling time, CL/f apparent total body clearance of drug following extravascular administration, Cmax maximum observed concentration, GCV geometric coefficient of variation, PK pharmacokinetics, t½ apparent terminal half-life, tmax time to reach the maximum observed concentration, Vz/f apparent volume of distribution during the terminal phase following extravascular administration