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. 2018 Jan 18;12(1):e0006020. doi: 10.1371/journal.pntd.0006020

Table 4. PK parameters of IVM for entire study population and by the 3 weight strata.

WA-ref: weight adjunted reference group (200 μg/kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).

Parameters
(raw data)
 WA-ref FD18 FD36
Arithmetic mean (SD)
Median [min- max] 		Arithmetic mean (SD)
Median [min- max] 		Arithmetic mean (SD)
Median [min- max]
All study groups (n = 54)
AUC0t (ng·h/mL) 860.13 (384.13)
830.09 [247.01–1795.24]		 885.92 (514.23)
792.60 [154.49–2340.65]		 1500.40 (838.40)
1440.83 [353.68–3908.27]
AUC0∞ (ng·h/mL) 1087.81 (505.16)
1013.01 [323.20–2245.68]		 1132.50 (684.05)
1057.84 [179.36–3065.69]		 1906.68 (1136.50)
1629.30 [410.34–5487.41]
Cmax (ng/mL) 43.19 (18.11)
44.52 [22.28–77.22]		 45.23 (24.29)
38.09 [11.17–103.48]		 78.04 (43.11)
65.49 [20.91–199.97]
tmax 4.15 (1.20)
4.00 [2.00–8.00]		 4.33 (1.94)
4.00 [2.00–16.00]		 4.11 (1.07)
4.00 [2.00–8.00]
t1/2 (h) 80.66 (33.33)
76.73 [24.90–177.28]		 80.98 (48.51)
67.36 [18.04–333.76]		 90.56 (58.17)
75.44 [30.37–372.02]
V/F (L) 1822.29 (857.21)
1592.81 [627.07–4321.88]		 2266.20 (1215.22)
2012.66 [704.01–6719.59]		 3000.97 (1677.28)
2747.62 [798.15–8063.24]
Cl/F(L/h) 17.31 (9.16)
15.29 [5.34–46.41]		 24.40 (19.14)
17.02 [5.87–100.36]		 27.33 (17.71)
22.10 [6.56–87.73]
Group 1 (n = 18)
AUC0t (ng·h/mL) 866.62 (435.52)
834.27 [293.95–1795.24]		 1112.80 (547.60)
1077.67 [393.25–2340.65]		 1787.67 (930.102)
1625.34 [353.68–3387.34]
AUC0∞ (ng·h/mL) 1040.85 (521.02)
980.15 [353.27–2245.68]		 1322.69 (707.92)
1265.90 [495.75–3065.69]		 2230.69 (1362.14)
1857.52 [410.34–5487.41]
Cmax (ng/mL) 44.76 (19.47)
45.33 [16.12–86.42]		 56.09 (24.73)
52.19 [21.62–103.48]		 96.20 (52.11)
71.80 [14.16–99.99]
tmax 4.08 (0.96)
4.00 [2.00–6.00]		 4.08 (1.30)
3.50 [2.00–8.00]		 4.19 (0.94)
4.00 [3.00–6.00]
t1/2 (h) 68.18 (34.43)
59.15 [24.90–177.28]		 66.85 (22.23)
62.77 [28.00–105.46]		 84.63 (75.13)
65.55 [30.37–372.02]
V/F (L) 1272.55 (595.04)
1209.17 [627.07–2967.48]		 1581.69 (818.77)
1317.25 [704.01–3528.47]		 2277.92 (1129.88)
2356.62 [798.15–3844.33]
Cl/F(L/h) 15.01 (8.70)
12.26 [5.34–33.97]		 17.73 (9.36)
14.23 [5.87–36.31]		 24.40 (19.06)
19.38 [6.56–87.73]
Mean time above 16ng/mL (h) 10 10 22
Group 2 (n = 18)
AUC0t (ng·h/mL) 778.37 (333.93)
675.74 [247.01–1571.48]		 711.90 (447.43)
639.94 [169.55–1851.18]		 1298.22 (813.86)
1341.78 [499.78–3908.27]
AUC0∞ (ng·h/mL) 963.30 (401.19)
878.59 [323.20–1842.72]		 890.81 (530.21)
806.42 [223.42–2298.88]		 1656.78 (1053.15)
1609.95 [569.29–4655.96]
Cmax (ng/mL) 38.18 (16.68)
39.34 [13.86–73.59]		 37.94 (22.55)
31.72 [11.17–90.81]		 65.39 (34.53)
65.49 [21.97–144.45]
tmax 4.25 (1.57)
4.00 [3.00–8.00]		 4.17 (1.21)
3.75 [3.00–8.00]		 3.64 (0.89)
3.50 [2.00–5.00]
t1/2 (h) 77.46 (26.78)
76.73 [35.46–126.80]		 75.32 (30.56)
64.49 [31.21–131.04]		 91.77 (56.18)
79.47 [32.43–271.77]
V/F (L) 1978.44 (890.34)
2051.55 [814.86–3963.29]		 2712.47 (1383.54)
2403.01 [1011.58–6719.59]		 3488.51 (1846.32)
3230.07 [837.49–7101.50]
Cl/F(L/h) 18.80 (9.73)
17.08 [8.14–46.41]		 29.44 (20.53)
22.44 [7.83–80.57]		 30.73 (17.71)
22.36 [7.73–63.24]
Mean time above 16ng/mL (h) 8 8 14
Group 3 (n = 18)
AUC0t (ng·h/mL) 935.41 (381.72)
862.69 [376.98–1641.39]		 833.05 (484.58)
792.60 [154.49–1706.92]		 1415.33 (725.01)
1456.71 [433.14–2858.74]
AUC0∞ (ng·h/mL) 1259.27 (559.71)
1153.64 [524.27–2235.71]		 1184.00 (757.37)
1128.59 [179.36–2606.35]		 1832.58 (937.65)
1677.87 [532.32–3296.75]
Cmax (ng/mL) 46.64 (17.98)
44.52 [22.28–80.61]		 41.65 (22.91)
37.08 [12.54–101.36]		 72.52 (36.54)
75.16 [20.91–132.46]
tmax 4.11 (1.05)
3.75 [3.00–6.00]		 4.75 (2.98)
4.00 [3.00–16.00]		 4.5 (1.21)
4.50 [3.00–8.00]
t1/2 (h) 96.33 (33.55)
100.47 [31.54–148.23]		 100.78 (72.43)
77.67 [18.04–333.76]		 95.30 (41.05)
97.15 [36.35–185.58]
V/F (L) 2215.89 (796.42)
2065.75 [1346.79–4321.88]		 2504.44 (1119.11)
2438.91 [847.94–4705.04]		 3236.49 (1794.78)
2790.83 [1119.26–8063.24]
Cl/F(L/h) 18.12 (9.09)
16.14 [8.25–34.33]		 26.04 (23.57)
15.97 [6.91–100.36]		 26.86 (16.72)
21.54 [10.92–67.63]
Mean time above 16ng/mL (h) 10 8 14