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Table 4 Point estimate and 90% confidence interval for the geometric mean ratios of C max , AUC (0-t) and AUC (0-inf) for THC/CBD spray in combination with rifampicin, ketoconazole and 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

  90% confidence limits
Analyte/PK variable Number of subjects Estimate Lower Upper
  Rifampicin and THC/CBD spray
THC/Cmax 12 0.614 0.525 0.719
THC/AUC(0-t) 12 0.711 0.617 0.820
THC/AUC(0-inf) 11 0.761 0.667 0.868
CBD/Cmax 12 0.480 0.420 0.550
CBD/AUC(0-t) 12 0.381 0.274 0.529
CBD/AUC(0-inf) 10 0.422 0.265 0.673
11-OH-THC/Cmax 12 0.140 0.120 0.163
11-OH-THC/AUC(0-t) 12 0.099 0.088 0.113
11-OH-THC/AUC(0-inf) 11 0.131 0.115 0.150
  Ketoconazole and THC/CBD spray
THC/Cmax 11 1.252 1.043 1.503
THC/AUC(0-t) 11 1.770 1.385 2.263
THC/AUC(0-inf) 10 1.840 1.446 2.342
CBD/Cmax 11 1.961 1.497 2.569
CBD/AUC(0-t) 11 2.715 2.047 3.601
CBD/AUC(0-inf) 9 1.923 1.560 2.370
11-OH-THC/Cmax 11 3.074 2.705 3.493
11-OH-THC/AUC(0-t) 11 3.823 3.405 4.292
11-OH-THC/AUC(0-inf) 10 3.616 3.181 4.111
  Omeprazole and THC/CBD spray
THC/Cmax 12 1.125 0.842 1.501
THC/AUC(0-t) 12 0.964 0.643 1.445
THC/AUC(0-inf) 12 0.962 0.668 1.386
CBD/Cmax 12 1.320 0.938 1.859
CBD/AUC(0-t) 12 1.326 0.756 2.325
CBD/AUC(0-inf) 11 1.096 0.745 1.611
11-OH-THC/Cmax 12 0.866 0.700 1.073
11-OH-THC/AUC(0-t) 12 0.869 0.629 1.201
11-OH-THC/AUC(0-inf) 12 0.869 0.641 1.179