Table 8.
Observed and predicted values of the internal validation (Xarelto 20 mg tablet fasted condition) and predicted values of theXarelto 20 mg tablet fed condition.
| Formulation | Parameter | Predicted | Observed a | %PE | Ratio |
|---|---|---|---|---|---|
| Xarelto 20 mg tablet Fasted condition | AUClast (µg·h/L) | 1381.946 | 1361.125 | 1.52966 | 1.015297 |
| Xarelto 20 mg tablet Fasted condition | Cmax (µg/L) | 143.567 | 146.000 | −1.66657 | 0.983334 |
| Xarelto 20 mg tablet Fasted condition | Tmax (h) |
3.0 | 1.5 | N/A | N/A |
| Xarelto 20 mg tablet Fed condition | AUClast (µg·h/L) | 1543.120 | 1750.175 | 13.41790 | 1.134179 |
| Xarelto 20 mg tablet Fed condition | Cmax (µg/L) | 174.566 | 241.000 | 38.05670 | 1.380567 |
| Xarelto 20 mg tablet Fed condition | Tmax (h) | 2.0 | 3.0 | N/A | N/A |