Table 4.
Bioequivalence analysis of AAFP to OAA
| PK parameters | Average (raw data) | ANOVA model-based least-square mean (log scale) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AAFP 500 mg | OAA 1000 mg | Ratio (%) | AAFP 500 mg | OAA 1000 mg | Mean difference | (90% CI) | Geometric mean ratio | (90% CI of ratio) | |
| AUC0–∞ | 438.023 | 453.179 | 95.8 | 5.906 | 6.000 | −0.094 | (−0.182, −0.006) | 0.910 | (0.833–0.994)a |
| AUC0–t | 416.232 | 415.908 | 98.9 | 5.843 | 5.911 | −0.068 | (−0.160, 0.024) | 0.934 | (0.853–1.024)a |
| C max | 84.159 | 83.398 | 119.5 | 4.260 | 4.262 | −0.002 | (−0.148, 0.144) | 0.998 | (0.863–1.155)a |
| PK parameters | Average (raw data) | ANOVA model-based least-square mean (log scale) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AAFP 625 mg | OAA 1000 mg | Ratio (%) | AAFP 625 mg | OAA 1000 mg | Mean difference | (90% CI) | Geometric mean ratio | (90% CI of ratio) | |
| AUC0–∞ | 473.315 | 453.179 | 107.9 | 6.039 | 6.000 | 0.039 | (−0.049, 0.127) | 1.040 | (0.952–1.136)a |
| AUC0–t | 450.193 | 415.908 | 111.8 | 5.981 | 5.911 | 0.070 | (−0.022, 0.162) | 1.073 | (0.979–1.175)a |
| C max | 100.757 | 83.398 | 138.6 | 4.428 | 4.262 | 0.166 | (0.020, 0.312) | 1.181 | (1.020–1.366) |
| Statistics | AAFP 500 mg | AAFP 625 mg | OAA 1000 mg |
|---|---|---|---|
| N | 34 | 34 | 34 |
| Mean | 1.79 | 1.84 | 2.21 |
| SD | 1.12 | 0.97 | 1.44 |
| Median | 1.50 | 1.50 | 2.00 |
| Minimum | 0.50 | 0.50 | 0.50 |
| Maximum | 6.00 | 4.00 | 8.00 |
| 95% CI (mean) | (1.403, 2.186) | (1.501, 2.176) | (1.703, 2.709) |
| P value (Wilcoxon signed rank) | 0.2301 | 0.3041 |
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, OAA originator abiraterone acetate, PK pharmacokinetic, SD standard deviation
aThe 90% CI fell within the recommended 0.800–1.250 limits of bioequivalence when analyzed on a log scale