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. 2022 Nov 23;13:1027648. doi: 10.3389/fphar.2022.1027648

TABLE 3.

PK parameters.

200 mg BID (n = 10) 300 mg BID (n = 10) 400 mg BID (n = 10) 500 mg BID (n = 10)
Day 1
Tmax, h Median (range) 1.0 (0.5–1.5) 1.0 (0.5–2.0) 1.2 (0.5–1.5) 1.0 (0.5–1.5)
Cmax, ng/mL Mean ± SD (%CV) 1890 ± 836 (44.3) 2610 ± 950 (36.4) 3680 ± 1380 (37.5) 4070 ± 1770 (43.4)
GeoMean (%GeoCV) 1680 (63.1) 2440 (41.8) 3120 (92.9) 3570 (69.1)
AUC0-12h, h*ng/mL Mean ± SD (%CV) 4610 ± 1530 (33.2) 7520 ± 2910 (38.7) 10500 ± 4300 (41.1) 12800 ± 6120 (47.9)
GeoMean (%GeoCV) 4270 (50.0) 7100 (35.6) 9280 (67.0) 10900 (75.8)
Day 21
 Tmax, h Median (range) 1.0 (0.5–1.9) 1.0 (0.5–1.5) 1.5 (0.5–2.0) 1.0 (0.5–2.0)
 Cmax, ng/mL Mean ± SD (%CV) 2140 ± 921 (43.1) 3050 ± 1480 (48.6) 4200 ± 1470 (34.9) 4960 ± 1810 (36.5)
GeoMean (%GeoCV) 1910 (61.3) 2770 (47.7) 3840 (55.0) 4560 (51.5)
 AUC0-12h, h*ng/mL Mean ± SD (%CV) 5510 ± 1800 (32.7) 9780 ± 3750 (38.3) 14700 ± 5010 (34.0) 16800 ± 4900 (29.2)
GeoMean (%GeoCV) 5180 (42.3) 9180 (38.7) 13600 (50.9) 16000 (36.5)
 t1/2, h Mean ± SD (%CV) 3.2 ± 0.6 (19.3) 3.5 ± 0.6 (16.7) 3.3 ± 0.9 (26.9) 3.3 ± 0.5 (16.2)
GeoMean (%GeoCV) 3.14 (18.6) 3.48 (17.0) 3.26 (21.8) 3.30 (15.9)
 Vz/F, L Mean ± SD (%CV) 191 ± 93 (48.7) 174 ± 64.6 (37.2) 158 ± 111 (69.9) 156 ± 55.7 (35.8)
GeoMean (%GeoCV) 175 (44.3) 164 (36.2) 138 (51.6) 149 (30.9)
 CL/F, L/h Mean ± SD (%CV) 42.2 ± 23.1 (54.7) 34.8 ± 13.4 (38.4) 33.7 ± 24.4 (72.3) 33.4 ± 15.1 (45.3)
GeoMean (%GeoCV) 38.6 (42.3) 32.7 (38.7) 29.4 (50.9) 31.2 (36.5)
 Ctrough, ng/mL Mean ± SD (%CV) 73.3 ± 36.3 (49.6) 171 ± 107 (63.0) 258 ± 128 (49.6) 299 ± 108 (36.0)
GeoMean (%GeoCV) 66.1 (49.9) 146 (62.1) 229 (58.0) 280 (40.7)
 Racc, h Mean ± SD (%CV) 1.2 ± 0.2 (15.4) 1.3 ± 0.3 (22.2) 1.5 ± 0.4 (24.6) 1.6 ± 0.7 (45.0)
GeoMean (%GeoCV) 1.21 (15.8) 1.29 (30.1) 1.46 (24.9) 1.46 (43.1)

Data are mean ± SD, unless otherwise specified.