Table 2 PK parameters of AD16 in SAD group

T_max (h)

Median (range)

0.50 (0.25–2.00)

0.50 (0.25–2.00)

1.00 (0.33–2.00)

0.75 (0.33–2.00)

0.50 (0.33–1.00)

0.87 (0.50–1.00)

T_1/2z (h)

Mean ± SD (CV%)

6.46 ± 2.05 (31.80)

6.51 ± 1.16 (17.90)

6.34 ± 1.32 (20.88)

6.43 ± 1.46 (22.77)

6.47 ± 1.38 (21.42)

5.85 ± 1.20 (20.48)

Median (range)

5.42 (4.70–10.44)

6.38 (4.77–8.35)

6.58 (4.67–8.19)

6.27 (4.64–9.02)

6.94 (4.06–7.93)

5.54 (4.76–7.55)

C_max (ng/mL)

Mean ± SD (CV%)

181.6 ± 52.17 (28.73)

324.8 ± 67.70 (20.85)

582.0 ± 190.06 (32.66)

823.1 ± 164.87 (20.03)

1139.9 ± 174.69 (15.32)

1392.5 ± 404.34 (29.04)

Median (range)

209.50 (111–236)

355.50 (224–389)

511.50 (411–943)

856.00 (564–1000)

1190.00 (913–1420)

1385.00 (1010–1790)

AUC_0-t (h*ng/mL)

Mean ± SD (CV%)

974.23 ± 227.30 (23.33)

1876.42 ± 443.64 (23.64)

3991.79 ± 962.47 (24.11)

5672.23 ± 1715.99 (30.25)

6808.53 ± 2167.28 (31.83)

9726.83 ± 1577.54 (16.22)

Median (range)

934.84 (745.97–1294.06)

1820.15 (1302.29–2741.21)

3812.11 (2742.19–5444.71)

5193.31 (3921.47–8449.84)

6154.08 (4077.52–10,528.26)

9455.22 (8108.47–11,888.39)

AUC_0-∞ (h*ng/mL)

Mean ± SD (CV%)

999.52 ± 229.69 (22.98)

1942.97 ± 439.23 (22.61)

4056.10 ± 948.02 (23.37)

5772.89 ± 1715.49 (29.72)

6881.45 ± 2184.89 (31.75)

9771.35 ± 1632.07 (16.70)

Median (range)

965.56 (763.69–1317.42)

1883.37 (1337.48 –2789.17)

3833.06 (2817.34–5524.11)

5274.72 (4021.40–8646.43)

6186.26 (4129.88–10,620.99)

9472.10 (8121.11–12,020.10)

CL/F (mL/h)

Mean ± SD (CV%)

5231.05 ± 1148.84 (21.96)

5371.31 ± 1173.65 (21.85)

5166.19 ± 1174.41 (22.73)

5587.49 ± 1531.42 (27.41)

6336.59 ± 1956.32 (30.87)

6262.70 ± 984.38 (15.72)

Median (range)

5201.73 (3795.29–6547.13)

5321.49 (3585.30–7476.74)

5217.85 (3620.49–7098.89)

5760.56 (3469.64–7460.09)

6558.11 (3766.13–9685.51)

6335.51 (4991.64–7388.16)

V_d/F (mL)

Mean ± SD (CV%)

46,201.74 ± 6459.12 (13.98)

48,804.92 ± 3816.97 (7.82)

45,467.84 ± 4745.20 (10.44)

49,491.16 ± 7854.11 (15.87)

56,108.07 ± 9536.99 (17.00)

51,801.38 ± 5651.42 (10.91)

Median (range)

45,646.41 (38,311.17–57,183.13)

48,397.36 (43,203.97–54,977.22)

47,202.23 (38,391.01–50,999.27)

47,556.53 (37,375.58–60,281.43)

55,361.62 (38,758.73–71,727.88)

52,900.10 (44,111.04–57,292.49)

MRT_0-t (h)

Mean ± SD (CV%)

7.02 ± 2.62 (37.32)

7.07 ± 1.68 (23.70)

7.71 ± 1.63 (21.10)

7.73 ± 1.84 (23.76)

7.49 ± 2.10 (28.03)

7.96 ± 1.66 (20.83)

Median (range)

5.65 (4.82–11.04)

6.37 (5.4–10.18)

7.95 (5.72–9.85)

7.96 (5.15–10.68)

7.49 (4.39–10.20)

7.81 (6.45–10.53)