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Table 4 Summary of FHND9041 PK parameters in healthy subjects after single oral administration of FHND9041 capsules at different stages (Rifampicin + FHND9041 group, PKPS)

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

Phase(n)

Descriptive statisticians

Cmax (ng/mL)

Tmax (h)

AUC0 − last (ng·h/mL)

Tlast

(h)

AUC0 − inf (ng·h/mL)

CL/F (L/h)

Vz/F (L)

t1/2 (h)

Monotherapy Phase(n = 15)

n

15

15

15

15

15

15

15

15

65.6 ± 17.3 (26.4%)

3.00 (2.00, 12.00)

3936 ± 1039 (26.4%)

239.33 (168.00, 239.35)

4206 ± 1122 (26.7%)

20.7 ± 6.89 (33.3%)

1662 ± 512 (30.8%)

57.1 ± 11. 4 (20.0%)

Co-administration phase(n = 14a)

n

14

35.0 ± 11.3 (32.3%)

14

3.00 (2.00, 6.00)

14

691 ± 339 (49.1%)

14

71.33 (47.33, 143.33)

14

732 ± 345 (47.2%)

14

133 ± 66.3 (49.9%)

14

3179 ± 1154 (36.3%)

14

17.9 ± 5.03 (28.1%)

  1. 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