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Table 6 Plasma cannabidiol exposure parameters at day 1 (single dose) and day 10 (multiple dose) by clobazam use (pharmacokinetic [PK] population)

From: Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy

PK parameters Day 1 serial sampling (geometric mean, mean, CV%) Day 10 serial sampling (geometric mean, mean, CV%)
10 mg/kg/day 20 mg/kg/day 40 mg/kg/day 10 mg/kg/day 20 mg/kg/day 40 mg/kg/day
With clobazam
 Cmax (ng/mL) 41.6, 93.3 (144.6)b 52.9, 117.9 (129.1)b 90.6, 241.5 (148.3)f 91.5, 104.6 (55.1)b 127.6, 221.9 (121.4)g 453.7, 563.1 (61.4)h
 AUC(0–τ) (ng·h/mL)a 171.2, 246.4 (93.1)b 342.6, 650.9 (124.8)d 446.8, 960.5 (138.7)f 521.2, 575.2 (45.5)d 867.1, 1093 (71.4)g 3130, 3533 (49.1)h
 Cl/F (L/h/kg) 19.2, 24.2 (61.2)c 18.8, 30.6 (101.5)e 18.2, 32.8 (109.7)g 9.6, 10.7 (51.7)d 12.1, 15.2 (74.7)g 6.4, 7.2 (55.4)h
Without clobazam
 Cmax (ng/mL) 20.4, 24.8 (68.2)b 42.1, 103.1 (135.2)b 124.1, 277.6 (131.1)d 90.5, 134.7 (103.6)b 124.7, 218.3 (152.0)d 192.9, 245.1 (80.7)d
 AUC(0–τ) (ng·h/mL)a 86.9, 101.4 (61.2)b 179.2, 377.6 (149.8)b 511.6, 853.2 (110.5)d 494.5, 587.3 (53.7)b 809.3, 1102 (106.3)d 1245, 1608 (75.6)d
 Cl/F (L/h/kg) 35.9, 38.1 (41.0)c 10.0, 11.6 (47.9)b 22.2, 28.3 (67.2)e 10.1, 13.3 (105.0)b 12.6, 15.3 (57.3)d 16.1, 21.0 (77.8)d
Ratio of geometric means
 Cmax 2.04 1.26 0.73 1.01 1.02 2.35
 AUC(0–τ) 1.97 1.91 0.87 1.05 1.07 2.51
 Cl/F 0.53 1.88 0.82 0.95 0.96 0.40
  1. AUC(0τ) area under the concentration–time curve in plasma during the dosing interval for day 10, Cl/F apparent total body clearance following oral administration, for day 10, Cmax maximum plasma concentration, CV% coefficient of variation
  2. aAUC(0–t) is AUC(0–12) for day 1 and AUC(0–τ) for day 10
  3. bn = 10
  4. cn = 6
  5. dn = 9
  6. en = 4
  7. fn = 12
  8. gn = 8
  9. hn = 12