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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.