Effect of CYP3A4 inhibitor and induction on the pharmacokinetics and safety of FHND9041, a novel EGFR T790M inhibitor, in healthy Chinese

Table 5 Summary of Pharmacokinetic interaction statistical analysis for FHND9041 (Rifampicin + FHND9041 Group)

PK parameters	Monotherapy Phase		Co-administration Phase		Mean ratio (combination/alone)	mean ratio 90%CI	Intra-individual coefficient of variation (%)
PK parameters	N	Mean	N	Mean	Mean ratio (combination/alone)	mean ratio 90%CI	Intra-individual coefficient of variation (%)
C_max (ng/mL)	15	63.3	14^a	33.0	52.12	(41.95, 64.74)	33.88
AUC_{0 − last} (ng·h/mL)	15	3790	14^a	624	16.47	(13.34, 20.31)	32.51
AUC_{0 − inf} (ng·h/mL)	15	4046	14^a	668	16.51	(13.56, 20.09	30.30

Note: a: Subject RD022 withdrew informed consent during the monotherapy phase with Rifampicin, resulting in early termination of the trial without proceeding to the co-administration phase. Data from this subject were excluded from the statistical analysis of the co-administration phase

ISSN: 2050-6511