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.