- Natural product: Cannabis (Cannabis sativa)
- Associated study: Drug Approval Package: Epidiolex (Cannabidiol)
In Vivo Interaction Study
CBD Effect on N-desmethylclobazam Concentrations
Increased systemic exposure was detected.
From page 109 of "Clinical Pharmacology Biopharmaceutics Review"
Results
From page 109
Units for these values are NOT means but are instead a ratio of day 33 values:day 1 values
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Double-blind
Placebo-controlled
Randomized crossover
Multiple dosing
Females
Males
Patients
CYP2C19 intermediate metabolizer
CYP2C19 rapid metabolizer
CYP2C19 ultra-rapid metabolizer
20
"A total of 20 patients were randomized to receive 20 mg/kg/day of CBD or placebo on a 4:1 basis."
Predose; postdose: 15 and 30 m, 1, 1.5, 2, 4, 6, 12 and 24 h
Drug or Natural Product Administration
Oral
Not stated
Not stated
Not stated
31 d
Oral
Solution
20 mg/kg
BID
31 d
Not stated
10-day titration, 21 days at maintenance dose of 20 mg/kg/day