Table 3 Summary of PK parameters (primary PK population).

AUC_0-inf (h × ng/mL)

0

N/A

1

2080

4

2200 (591)

6

3700 (1220)

AUC_0-t (h × ng/mL)

1

666

1

1900

4

1980 (427)

8

3320 (1260)

C_max (ng/mL)

1

468

1

720

4

1150 (166)

8

1320 (815)

k_el (/h)

0

N/A

1

1.81

4

2.25 (1.57)

6

1.51 (0.46)

CL (mL/h/m²)

0

N/A

1

14,400

4

21,500 (6120)

6

17,800 (5880)

Vz (mL/m²)

0

N/A

1

7970

4

13,100 (6830)

6

12,900 (5520)

MRT_0-inf (h)

0

N/A

1

0.611

4

0.889 (0.393)

6

1.54 (0.66)

C_max/D (m² × ng/mL/mg)

1

23.4

1

24

4

25.6 (3.68)

8

22 (13.6)

AUC_0-inf/D (h × [ng/mL] × m²/mg)

0

N/A

1

69.5

4

49.3 (13.1)

6

61.7 (20.4)

AUC_0-t/D (h × [ng/mL] × m²/mg)

1

33.3

1

63.5

4

44 (9.49)

8

55.4 (21.1)

t_{1/2 el} (h) Median [Min;Max]

0

N/A

1

0.38 [N/A]

4

0.45 [0.19;0.87]

6

0.48 [0.31;0.70]

t_max (h) Median [Min;Max]

1

2.02 [N/A]

1

2.98 [N/A]

4

2.37 [1.32;2.82]

8

4.75 [1.60;9.12]

t_last (h) Median [Min;Max]

1

2.17 [N/A]

1

3.32 [N/A]

4

2.77 [2.25;3.82]

8

5.13 [3.23;9.62]