Table 2.
Pharmacokinetic Parameters of Glimepiride After Administration of Test and Reference Formulations Under Fasted or Fed Conditions
| Fasted | Fed | |||
|---|---|---|---|---|
| Parameter | Test (N=35) | Reference (N=36) | Test (N=35) | Reference (N=36) |
| Tmax, h | 4.8 (1.61) | 4.8 (1.62) | 3.9 (1.30) | 3.8 (1.12) |
| Cmax, ng/mL | 75.1 (26.32) | 77.8 (21.13) | 130.2 (36.04) | 119.7 (32.68) |
| AUC0-t, ng/mL/h | 406.8 (144.85) | 403.2 (141.16) | 627.0 (168.56) | 602.5 (178.26) |
| AUC0-inf, ng/mL/h | 424.6 (154.29) | 427.1 (149.51) | 640.8 (174.64) | 617.0 (184.77) |
| λz, 1/h | 0.136 (0.043) | 0.125 (0.046) | 0.150 (0.046) | 0.156 (0.059) |
| t1/2, h | 5.513 (1.542) | 6.295 (2.305) | 4.998 (1.255) | 5.005 (1.795) |
Note: Data are expressed as mean (SD).
Abbreviations: AUC, area under the curve; AUC0-t, AUC from time 0 to the time of the last quantifiable concentration; AUC0-inf, AUC from time 0 extrapolated to infinity; Cmax, maximum observed plasma concentration; Tmax, observed time to reach Cmax; t1⁄2, apparent terminal elimination half-life; λz, terminal log-linear phase.