Table 2 PK parameters of rivaroxaban derived via NCA (12–18 years and 6–12 years) or PopPK analysis (geometric mean/CV [range])
12–18 years | 6–12 years | 2–6 years | 0.5–2 years | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Tablet rivaroxaban 10 mg eq. (n = 4) | Table trivaroxaban 20 mg eq. (n = 5) | Tablet rivaroxaban 10 mg eq. (n = 4) | Suspension rivaroxaban 10 mg eq. (n = 11) | Tablet rivaroxaban 20 mg eq. (NCA n = 4, PopPK n = 5) | Suspension rivaroxaban 20 mg eq. (n = 5) | Suspension rivaroxaban 10 mg eq. (n = 11) | Suspension rivaroxaban 20 mg eq. (n = 5) | Suspension rivaroxaban 10 mg eq. (n = 6) | Suspension rivaroxaban 20 mg eq. (n = 4) | ||
AUC0–24 (μg•h l−1) | PopPK | 1320/13.1 (1090–1450) | 1760/20.7 (1270–2090) | 902/31.2 (645–1340) | 720/24.1 (443–1120) | 1540/52.0 (917–2390) | 1070/37.5 (784–1700) | 674/25.5 (433–976) | 755/39.0 (476–1110) | 503/20.6 (373–660) | 672/29.4 (461–929) |
NCA | 1340/37.7 (788–1760) | 1660/39.0 (968–2560) | 866/36.0 (614–1410) | 719/42.4 (293–1380) | 1650/38.9 (1050–2410) | 1060/48.0 (572–1890) | |||||
Cmax (μg l−1) | PopPK | 129/11.4 (115–143) | 180/12.0 (148–200) | 118/11.0 (105–136) | 82.5/37.4 (47.2–137) | 172/25.9 (128–218) | 85.1/15.7 (72.1–106) | 84.2/36.0 (46.7–132) | 60.1/33.4 (44.9–92.6) | 94.9/28.3 (56.0–125) | 143/14.7 (118–169) |
NCA | 161/45.6 (84.5–213) | 206/41.3 (121–302) | 115/72.6 (44.9–195) | 89.2/59.3 (42.0–224) | 244/21.1 (198–325) | 113/42.9 (77.0–208) | |||||
C_24ha (μg l− 1) | PopPK | 7.94/35.4 (5.25–12.2) | 9.46/55.6 (4.42–16.5) | 3.18/73.9 (1.71–7.52) | 3.35/57.6 (0.873–5.69) | 8.46/98.5 (3.45–19.0) | 7.18/96.1 (3.27–18.0) | 3.27/65.0 (1.11–7.61) | 5.71/129 (1.25–18.2) | 1.94/33.5 (1.19–2.87) | 2.39/39.9 (1.56–3.95) |
NCA | 9.55/30.0 (7.10–13.3) | 11.9/77.0 (4.47–24.3) | 3.43/127 (1.27–11.2) | 4.18/64.0 (0.952–8.20) | 12.5/128 (3.87–35.4) | 7.44/123 (2.81–19.2) | |||||