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Table 2 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 ketoconazole

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 ketoconazole (n = 11)
  THC
AUC(0-t) (h*ng/mL) 8.19 (5.67) 15.38 (13.43)
AUC(0-inf) (h*ng/mL) 9.22 (5.94)a 16.76 (13.80)
Cmax (ng/mL) 2.65 (1.32) 3.36 (1.65)
Tmax (h) 1.50 (0.75-6.00) 1.75 (1.00-3.00)
Kel (h-1) 0.258 (0.092)a 0.189 (0.078)
t½ (h) 3.07 (1.31)a 4.43 (2.19)
CL/F (L/h) 1504 (688)a 920 (450)
Varea/F (L) 6328 (4164)a 5111 (2221)
  CBD
AUC(0-t) (h*ng/mL) 1.82 (1.03) 4.83 (2.01)
AUC(0-inf) (h*ng/mL) 3.54 (0.80)b 6.50 (2.23)c
Cmax (ng/mL) 0.66 (0.37) 1.25 (0.51)
Tmax (h) 1.38 (0.75-6.00) 1.75 (1.00-2.52)
Kel (h-1) 0.122 (0.111)b 0.143 (0.066)c
t½ (h) 7.81 (3.00)b 6.54 (4.59)c
CL/F (L/h) 2998 (896)b 1731 (650)c
Varea/F (L) 31994 (12794)b 14349 (7076)c
  11-OH-THC
AUC(0-t) (h*ng/mL) 21.78 (11.34) 84.34 (40.18)
AUC(0-inf) (h*ng/mL) 27.13 (13.34)d 95.26 (48.93)
Cmax (ng/mL) 3.59 (1.67) 10.92 (3.83)
Tmax (h) 1.50 (1.00-6.00) 2.25 (1.50-4.13)
Kel (h-1) 0.076 (0.014)d 0.095 (0.016)
t½ (h) 9.51 (2.18)d 7.48 (1.39)
  1. Data presented are mean and (SD) except for Tmax where median and range are shown, a n=11; bn=9; cn=10; dn=11.