Table 3.
Analysis of Bioequivalence for Plasma Pharmacokinetic Parameters of Glimepiride Under Fasted or Fed Conditions
| Parameter | Fasted | Fed | ||||||
|---|---|---|---|---|---|---|---|---|
| Ratio (% Ref) | 90% CI (Lower, Upper) | CV (%) | Power (%) | Ratio (% Ref) | 90% CI (Lower, Upper) | CV (%) | Power (%) | |
| Cmax (ng/mL) | 94.27 | (86.09, 103.23) | 22.72% | 91.7 | 107.66 | (97.88, 118.42) | 23.87 | 83.7 |
| AUC0-t (h*ng/mL) | 102.68 | (99.82, 105.62) | 6.99% | 99.9 | 103.58 | (99.53, 107.80) | 9.89 | 99.9 |
| AUC0-inf (h*ng/mL) | 101.11 | (98.45, 103.84) | 6.59% | 99.9 | 103.38 | (99.26, 107.68) | 10.08 | 99.9 |
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; CV, coefficient of variation in vivo; Power, power of test.