Table 2.
Pharmacokinetic parameter (unit) | Treatment Aa (n = 8) | Treatment Ba (n = 8) | Treatment Ca (n = 8) | Treatment Da (n = 8) | ||||
---|---|---|---|---|---|---|---|---|
Day 1 | Day 7 | Day 1 | Day 7 | Day 1 | Day 7 | Day 1 | Day 7 | |
Cmax (ng/mL)b | 2.4 (43.6)d | 2.8 (6.6)e | 3.6 (60.1)f | 4.0 (56.3)g | 4.8 (20.9)f | 4.2 (43.1) | 6.6 (31.9)h | 6.7 (42.6)g |
tmax (h)c | 3.2 (0.0–4.3)d | 1.6 (1.3–2.0)e | 2.3 (2.0–4.5)f | 2.3 (2.0–4.3)g | 4.3 (4.2–4.4)f | 4.3 (2.3–4.3) | 3.4 (2–12.3)h | 2.3 (2.3–8.3)g |
AUC0–t (ng*h/mL)b | 2.2 (75.2)i | 2.3 (35.0)e | 5.6 (83.9)f | 5.9 (74.1)g | 9.0 (41.4)f | 9.9 (47.3) | 17.6 (37.4)h | 26.8 (31.6)g |
AUC0–12 (h*ng/mL)b | - | 5.7 (3.4)e | - | 9.0 (46.3)g | - | 13.6 (34.5) | - | 29.5 (26.5)g |
AUC0–inf (h*ng/mL)b | NE | NE | NE | NE | NE | 44.2 (6.9)e | NE | 107.8 (-)j |
% extrapolated (AUC12–∞/AUC0–∞)b | NE | NE | NE | NE | NE | 18.22% (5.91%)e | NE | 26.6% (-)j |
CL/F (L/h)b | - | NE | - | NE | - | 0.22 (17.4)e | - | 0.12 (-)j |
Concentrations that were below the lower limit of quantification were assigned as zero for analysis. AUC0–12 area under the plasma concentration–time curve from 0- to 12-h time point, AUC0–t area under the plasma concentration–time curve from 0 to the last quantifiable concentration, AUC0–inf area under the plasma concentration–time curve from 0 to infinity, CL/F oral clearance of drug from plasma, Cmax maximum observed plasma concentration, NE not estimable, tmax time to reach Cmax
aTreatment A: 120 mg CBD, 5.4 mg THC, and 6.6 mg CBC daily; Treatment B: 240 mg CBD, 10.8 mg THC, and 13.2 mg CBC daily; Treatment C: 360 mg CBD, 16.2 mg THC, and 19.8 mg CBC daily; and Treatment D: 480 mg CBD, 21.6 mg THC, and 26.4 mg CBC daily
bGeometric mean (geometric CV%)
cMedian (range)
dn = 4
en = 2
fn = 5
gn = 7
hn = 6
in = 3
jn = 1