Skip to main content

Table 5 Treatment emergent adverse events with an incidence >1

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

Primary system organ class Preferred term*

No. of subjects (%)

No. of subjects (%)

No. of subjects (%)

 

THC/CBD spray (n= 36)

Psychiatric disorders

Euphoric mood

2 (6)

-

-

Nervous system disorders

   

Dizziness

2 (6)

-

-

Dizziness postural

3 (8)

-

-

Headache

5 (14)

-

-

Somnolence

11 (31)

-

-

Gastrointestinal disorders

   

Nausea

2 (6)

-

-

 

Rifampicin ( n= 12 )

THC/CBD spray and Rifampicin ( n= 12 )

THC/CBD spray ( n= 12 )

Nervous system disorders

   

Dysgeusia

1 (8)

0

1 (8)

Headache

0

1 (8)

1 (8)

Somnolence

0

0

2 (17)

 

Ketoconazole ( n= 12 )

THC/CBD spray and Ketoconazole ( n= 11 )

THC/CBD spray ( n= 12 )

Nervous system disorders

   

Somnolence

0

4 (36)

4 (33)

Dizziness

0

3 (27)

2 (17)

Lethargy

0

3 (27)

0

Dysgeusia

0

2 (18)

0

Headache

0

2 (18)

0

Somnolence

0

1 (9)

1 (8)

Psychiatric disorders

   

Euphoric mood

0

7 (64)

0

Anxiety

0

1 (9)

1 (8)

Disorientation

0

1 (9)

1 (8)

 

Omeprazole ( n= 12 )

THC/CBD spray and Omeprazole ( n= 12 )

THC/CBD spray ( n= 12 )

Nervous system disorders

   

Dizziness

0

3 (25)

0

Dizziness postural

0

0

2 (17)

Headache

1 (8)

0

4 (33)

Somnolence

0

2 (17)

5 (42)

Gastrointestinal disorders

   

Dry mouth

0

2 (17)

1 (8)

  1. *MedDRA version 10.0.