Table 5.
Bioequivalence analysis of dose proportionality for AAFP 125 and 625 mg after dose normalization to 500 mg
| PK parameters | Average (raw data) | ANOVA model-based least-square mean (log scale) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AAFP 125 mg | AAFP 500 mg | Ratio (%) | AAFP 125 mg | AAFP 500 mg | Mean difference | (90% CI) | Geometric mean ratio | (90% CI of ratio) | |
| AUC0–∞ | 448.472 | 436.075 | 107.4 | 5.970 | 5.946 | 0.024 | (−0.077, 0.125) | 1.024 | (0.926–1.133)a |
| AUC0–t | 410.206 | 414.087 | 104.0 | 5.869 | 5.886 | −0.017 | (−0.125, 0.091) | 0.983 | (0.882–1.096)a |
| C max | 112.884 | 82.452 | 155.2 | 4.583 | 4.303 | 0.28 | (0.113, 0.447) | 1.323 | (1.119–1.564) |
| PK parameters | Average (raw data) | ANOVA model-based least-square mean (log scale) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AAFP 625 mg | AAFP 500 mg | Ratio (%) | AAFP 625 mg | AAFP 500 mg | Mean difference | (90% CI) | Geometric mean ratio | (90% CI of ratio) | |
| AUC0–∞ | 394.271 | 438.023 | 96.9 | 5.881 | 5.946 | −0.065 | (−0.165, 0.035) | 0.937 | (0.848–1.035)a |
| AUC0–t | 375.011 | 416.232 | 97.9 | 5.826 | 5.886 | −0.060 | (−0.167, 0.047) | 0.942 | (0.846–1.048)a |
| C max | 83.931 | 84.159 | 105.6 | 4.276 | 4.303 | −0.027 | (−0.192, 0.138) | 0.973 | (0.826–1.148)a |
AAFP abiraterone acetate fine particle, ANOVA analysis of variance, AUC 0–∞ area under the plasma concentration–time curve from time zero to infinity, AUC 0–t area under the plasma concentration–time curve from time zero to the time of the last quantifiable concentration, CI confidence interval, C max maximum plasma concentration, PK pharmacokinetic
aThe 90% CI fell within the recommended 0.800–1.250 limits of bioequivalence when analyzed on a log scale