TABLE 3.
Comparison of measured PK values following oral administration of 1 mg varenicline in Americans and simulated PK values in 300 American virtual subjects.
| Parameter | Simulated value | Parameter | Measured value | ||||
|---|---|---|---|---|---|---|---|
| Mean | Standard error | Coefficient of variation (%) | Mean | Standard error | Coefficient of variation (%) | ||
| Cmax (ng/ml) | 4.58 | 1.48 | 32.40 | Cmax (ng/ml) | 4.63 | 2.02 | 53.00 |
| AUC0-t (h*ng/mL) | 103.73 | 37.54 | 36.19 | AUC0-t (h*ng/mL) | 98.74 | 25.49 | 25.80 |
| AUC0-∞ (h*ng/mL) | 105.80 | 40.35 | 38.14 | AUC0-∞ (h*ng/mL) | 102.53 | 26.82 | 26.20 |
| T1/2 (h) | 15.05 | 8.15 | 54.13 | T1/2 (h) | 19.59 | 10.39 | 53.00 |
| Median | Minimum | Maximum | Median | Minimum | Maximum | ||
| Tmax (h) | 4.00 | 2.00 | 6.00 | Tmax (h) | 3.00 | 1.00 | 6.00 |
Cmax, maximum concentration; AUC0-t, area under the plasma concentration vs. time curve from the start of the last dose to the last time at which there is a quantifiable concentration; AUC0-∞, AUC0-t extrapolated to infinity; T1/2, apparent terminal elimination half-life; Tmax, time to Cmax.