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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.