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Table 2 PK parameters of rivaroxaban derived via NCA (12–18 years and 6–12 years) or PopPK analysis (geometric mean/CV [range])

From: Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study

  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)     
  1. aC_24h derived via NCA here indicates the concentration obtained in the last sampling interval, i.e. 20–24 h after rivaroxaban administration
  2. AUC0–24, area under the plasma concentration–time curve from time 0–24 h; Cmax, maximal plasma concentration; NCA, non-compartmental analysis; C_24h, plasma concentration 24 h after rivaroxaban administration; eq., equivalent; PopPK, population pharmacokinetic