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).