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Table 3 Summary of pharmacokinetic parameters of THC, CBD and 11-OH-THC after a single dose of THC/CBD (4 sprays) alone or in combination omeprazole

From: A Phase I, open-label, randomized, crossover study in three parallel groups to evaluate the effect of Rifampicin, Ketoconazole, and Omeprazole on the pharmacokinetics of THC/CBD oromucosal spray in healthy volunteers

Parameter THC/CBD spray alone (n = 12) THC/CBD spray and omeprazole (n = 12)
  THC
AUC(0-t) (h*ng/mL) 8.76 (8.62) 7.41 (4.75)
AUC(0-inf) (h*ng/mL) 9.39 (8.81) 8.10 (4.78)
Cmax (ng/mL) 2.50 (1.85) 2.48 (1.06)
Tmax (h) 1.25 (0.77-3.02) 1.25 (1.00-1.75)
Kel (h-1) 0.305 (0.109) 0.357 (0.218)
t½ (h) 2.65 (1.25) 2.37 (0.92)
CL/F (L/h) 2161 (1990) 2284 (2520)
Varea/F (L) 6889 (5296) 6052 (3384)
  CBD
AUC(0-t) (h*ng/mL) 1.83 (1.19) 2.25 (1.51)
AUC(0-inf) (h*ng/mL) 3.00 (1.43)a 3.33 (1.77)
Cmax (ng/mL) 0.63 (0.43) 0.73 (0.30)
Tmax (h) 1.15 (0.50-3.02) 1.25 (0.48-1.75)
Kel (h-1) 0.224 (0.158)a 0.210 (0.114)
t½ (h) 5.22 (4.51)a 5.46 (6.13)
CL/F (L/h) 4741 (3845)a 4772 (4550)
Varea/F (L) 26298 (14532)a 24757 (16311)
  11-OH-THC
AUC(0-t) (h*ng/mL) 21.52 (14.76) 17.69 (9.05)
AUC(0-inf) (h*ng/mL) 24.17 (16.47) 19.80 (9.74)
Cmax (ng/mL) 3.48 (2.27) 2.84 (1.40)
Tmax (h) 2.00 (1.25-3.02) 1.52 (1.23-2.50)
Kel (h-1) 0.114 (0.062) 0.095 (0.029)
t½ (h) 7.30 (2.87) 7.98 (2.82)
  1. Data presented are mean and (SD) except for Tmax where median and range are shown, an=11.