Table 3.
Maternal mean total systemic exposure in the rat and rabbit.
| Sampling Day | Dose (mg/kg/day) |
Mean Systemic Exposure |
Exposure Margina |
|||
|---|---|---|---|---|---|---|
| Cmax (μg/mL) |
AUC24 (μgh•/mL) |
Cmax | AUC24 | |||
| Rat EFD Study | GD 17 | 100 | 29.0 ± 11.0 | 75.5 ± 12.4 | 7.0x | 1.1x |
| 300 | 43.2 ± 14.4 | 346 ± 92.0 | 10x | 5.0x | ||
| 1000 | 65.4 ± 18.7 | 535 ± 330 | 16x | 7.8x | ||
| Rabbit EFD Study | GD 19 | 100 | 17.0 ± 6.1 | 98.7 ± 27.4 | 4.1x | 1.4x |
| 300 | 42.9 ± 11.1 | 195 ± 56.8 | 10x | 2.8x | ||
| 1000 | 99.6 ± 46.5 | 689 ± 206 | 24x | 10x | ||
a
Calculated using animal total exposures relative to predicted human total PF-07321332 Cmax of 4.14 μg/mL and AUC24 of 68.6 μg h/mL at a twice daily dose of 300/100 mg PF-07321332/ritonavir.