CBD effect on CLB and N-desmethylclobazam CSV JSON

Natural product: Cannabis (Cannabis sativa)
Associated study: Drug Approval Package: Epidiolex (Cannabidiol)

In Vivo Interaction Study

CBD effect on CLB and N-desmethylclobazam

Increased systemic exposure was detected.

Object compound

clobazam

Precipitant

cannabidiol

Study GWEP1543

Results

Clobazam exposure was increased slightly (~20%) by co-administration with CBD while exposure to the n-desmethylclobazam metabolite was increased by 3.4 fold as a result of concommitant CBD.

Sample	Compound measured	Value	Measurement	Study sequence	Additional information	N replicates

Experimental Conditions

Study design

Fixed-sequence
Parallel
Multiple dosing

Population

Demographic characteristics

Females
Healthy volunteers
Males

Number of subjects

Population additional information

Arm 1, Group 1

Drug or Natural Product Administration

Object Administration — clobazam

Administration route

Oral

Formulation

Not specified

Total daily dose

10 mg

Interval/frequency

5 mg BID

Duration

14 days

Precipitant Administration — cannabidiol

Administration route

Oral

Formulation

Solution

Total daily dose

1500 mg

Interval/frequency

750 mg BID

Duration

14 days

Natural Product Characteristics

Year sourcing was completed