- Natural product: Cannabis (Cannabis sativa)
- Associated study: Drug Approval Package: Epidiolex (Cannabidiol)
In Vivo Interaction Study
CBD Effect on clobazam and N-desmethylclobazam
No Effect (based on bioequivalence limits) was detected.
Study GWEP1428 (p 106)
Results
Test ratios indicate the Day33:Day 1 ratio for individuals allocated to active drug.
Control ratios indicate the Day 33:Day ratio for individuals allocated to placebo.
CBD did not alter Cmax or AUC of clobazam but did increase exposure to the N-desmethylclobazam metabolite.
Data from page 109
| 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; post-dose: 15 and 30 m, 1, 1.5, 2, 4, 6, 12, 24 hr
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 maintenance of 20 mg/kg/day; CBD/placebo was taken twice daily immediately after patients' clobazam dose