Clinically observed and PBPK model-predicted pharmacokinetic parameters of bosutinib in subjects after single and multiple oral administrations of 500 mg bosutinib once daily
Data are expressed as geometric means with percent coefficients of variation in parentheses (n = 3 in the observed results in CPs, n = 12 in the observed results in HVs, and n = 100 in the predicted results; 10 individuals × 10 groups).
| Population | Analysis | Single Dose | Multiple Doses | ||
|---|---|---|---|---|---|
| Cmax | AUC | Cmax | AUC | ||
| ng/ml | ng⋅h/ml | ng/ml | ng⋅h/ml | ||
| CPs | Observed | 97 (35) | 2030 (23) | 200 (72) | 3640 (51) |
| Predicted | 74 (55) | 1789 (58) | 135 (63) | 2403 (69) | |
| P/O | 0.8 | 0.9 | 0.7 | 0.7 | |
| HVs | Observed | 95 (39) | 2193 (38) | ― | ― |
| Predicted | 80 (47) | 2445 (65) | ― | ― | |
| P/O | 0.8 | 1.1 | ― | ― | |
Dashes indicate not applicable.