Table 5.
Results from the in vivo pharmacokinetic (PK) study in male beagle dogs.
| Generic Abiraterone Acetate Tablet (250 mg Abiraterone Acetate) | Lot 2 Tablet (44.6 mg Abiraterone) | Lot 5 Tablet (44.6 mg Abiraterone) | Lot 6 Tablet (44.6 mg Abiraterone) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| PK parameters | Units | Average | %CV | Average | %CV | Average | %CV | Average | %CV |
| Cmax | ng/mL | 86.32 | 66.57% | 53.58 | 58.84% | 280.00 | 33.51% | 305.00 | 20.72% |
| Tmax | hr | 1.20 | 37.27% | 1.20 | 55.90% | 0.80 | 34.23% | 0.70 | 39.12% |
| T1/2 | hr | 4.78 | 50.70% | 3.12 | 42.20% | 2.30 | 32.30% | 3.47 | 28.90% |
| AUC0–10 h | ng*hr/mL | 177.29 | 77.53% | 122.21 | 25.64% | 438.01 | 34.29% | 487.58 | 14.11% |
| F Value (Dose Adjusted) | unitless | 1.0 | 3.4 | 12.4 | 13.8 | ||||