Table 3.
Statistical Comparison After Ln-Transformed Cmax, AUC0-t and AUC0-∞of the Test and Reference Formulations Under Fasting Conditions (n = 21)
| Parameter | Geometric Mean | Geometric Mean Ratio (%) | 90% CI (%) | CV (%) | Power (%) | |
|---|---|---|---|---|---|---|
| Test | Reference | |||||
| Cmax (ng/mL) | 28.4 | 26.4 | 107.74 | 102.87, 112.85 | 8.69 | 100 |
| AUC0-t (h.ng/mL) | 966.79 | 953.23 | 101.42 | 97.85, 105.12 | 6.72 | 100 |
| AUC0-∞ (h.ng/mL) | 1018.02 | 1005.01 | 101.29 | 97.51, 105.23 | 7.15 | 100 |
Abbreviations: Cmax, the highest plasma concentration of the drug; AUC0–t, the area under the plasma concentration–time curve from time zero to the last quantifiable concentration time; AUC0-∞, the area under the plasma concentration–time curve from time zero extrapolated to infinite time.