3.1 Subject demographics
Among the 20 Chinese subjects, there were 13 males and 7 females; 18
were of Han nationality and 2 were of other nationalities. The median
age was 24.5 years (range 19–37 y), and the average height (± SD) was
168.38 ± 8.291 cm. The average body weight (± SD) was 69.09±10.337 kg,
and the average body mass index (± SD) was 24.26 ±2.333
kg/m2.
3.2 PK analysis
The main PK parameters of famitinib and its metabolite SHR116637 between
famitinib alone and co-administration with omeprazole were showed in
Tabel 1. No clinically significant difference was observed in theC max, AUC 0-t andAUC 0-∞ of famitinib between alone monotherapy and
co-administration with omeprazole. The
GMRs ofC max, AUC 0-t andAUC 0-∞ of famitinib were 98.9%, 95.6% and
95.3%, respectively. The exposure of the metabolite SHR116637 was
slightly decreased when famitinib was co-administered with omeprazole,
with the C max, AUC 0-t andAUC 0-∞ of SHR116637 decreased by 14.9%, 11.0%
and 11.3% upon co-administration. The GMRs ofC max, AUC 0-t andAUC 0-∞ for SHR116637 were 85.1%, 89.0% and
88.7%, respectively. Evaluation of drug interactions between famitinib
and omeprazole was shown in Table 2. The mean plasma concentration–time
curve is shown as Figure 2. The plasma concentrations of famitinib were
similar over time, and there was no significant change in PK parameters
between administration of
famitinib alone and co-administration with omeprazole.