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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.