PK data
Derived paclitaxel PK parameters are summarized in Tables 2 and 3 and Figure 2. Following administration of paclitaxel, mean time to peak concentration was approximately 1 hour post oral and IV dosing (figure 2). Mean terminal t½ was longer with oral dosing (43 hours) than after IV administration (26 hours). Mean Cmax following oral administration of paclitaxel was one‑seventh of that following IV administration. For oral administration, AUC0-∞was 5033.5 +/- 1401.1 ng.h/mL compared to 5595.9 +/- 1264.1 ng.h/mL with IV. The intrasubject coefficient of variation was 16.1%. Based on log transformed data, the geometric mean ratio (GMR) for AUC was 89.5% (90% CI 83.9-95.5). The 90% CI was within the predefined acceptable range of 80% to 125% for demonstrating bioequivalence. The mean absolute bioavailability of oral compared to IV paclitaxel was 12%. There was no difference in bioavailability or AUC by Asian compared to European ethnicity (Figure 3).