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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