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Table 1 Summary of pharmacokinetic parameters of THC, CBD and 11-OH-THC after a single dose of THC/CBD (4 sprays) alone or in combination with rifampicin

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 rifampicin (n = 12)
  THC
AUC(0-t) (h*ng/mL) 9.10 (2.98) 6.53 (2.70)
AUC(0-inf) (h*ng/mL) 9.86 (3.35)a 7.53 (2.99)
Cmax (ng/mL) 2.94 (1.21) 1.88 (1.07)
Tmax (h) 1.01 (0.50-6.02) 1.75 (1.25-2.57)
Kel (h-1) 0.197 (0.093)a 0.189 (0.071)
t½ (h) 4.68 (3.42) a 4.93 (3.91)
CL/F (L/h) 1207 (373)a 1595 (473)
Varea/F (L) 7625 (4326)a 10297 (5888)
  CBD
AUC(0-t) (h*ng/mL) 3.23 (2.13) 1.31 (0.89)
AUC(0-inf) (h*ng/mL) 5.10 (3.06) 2.15 (0.94)b
Cmax (ng/mL) 1.03 (0.81) 0.50 (0.37)
Tmax (h) 1.00 (0.50-4.00) 1.50 (1.00-6.00)
Kel (h-1) 0.148 (0.108) 0.196 (0.092)b
t½ (h) 10.86 (12.71) 4.13 (1.65)b
CL/F (L/h) 2817 (1913) 5966 (3713)b
Varea/F (L) 28312 (19355) 34790 (20036)b
  11-OH-THC
AUC(0-t) (h*ng/mL) 18.61 (7.81) 1.84 (0.79)
AUC(0-inf) (h*ng/mL) 21.59 (8.76) 2.78 (0.68)c
Cmax (ng/mL) 3.38 (1.95) 0.45 (0.18)
Tmax (h) 1.38 (0.50-6.02) 1.75 (1.50-2.57)
Kel (h-1) 0.083 (0.042) 0.189 (0.074)c
t½ (h) 9.88 (3.89) 4.19 (1.62)c
  1. Data presented are mean and (SD) except for Tmax where median and range are shown, an=11; bn=10; cn=11.