CBD Effect on Midazolam CSV JSON

In Vivo Interaction Study

CBD Effect on Midazolam

No Effect (based on bioequivalence limits) was detected.

midazolam 708298

cannabidiol (cbd)

Systemic exposure to midazolam was relatively unaffected by concomitant administration of CBD indicating lack of inhibition or induction of CYP3A4. The increased exposure to 1'-hydroxymidazolam may be due to downstream inhibition of glucuronidation by UGT2B7. Further details can be found in "Clinical Pharmacology Biopharmaceutics Review(s)"

Results

C estimated from Fig 8; page 111

Sample Compound measured Value Measurement Study sequence Additional information N replicates

Experimental Conditions

Fixed-sequence
Single dosing

Population

Females
Healthy volunteers
Males

16

Pharmacokinetic (PK) Sampling Information

Predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 14, 18, 24 h

Drug or Natural Product Administration

Object Administration — midazolam

Oral

Solution

2.5 mg

Once

Once

Precipitant Administration — cannabidiol (cbd)

Oral

Solution

escalating dosing until 750 mg

BID

25 days

Natural Product Characteristics

Not stated

Information from Study GWEP17028 (starting page 109)

Subjects received a single 2.5 mg oral midazolam dose on Day -1 (reference). Subjects then recieved "escalating doses of CBD from Day 1 (250 mg once daily) to Day 11 (750 mg twice daily), followed by 14 days of 750 mg CBD b.i.d. (Days 12-25). On Day 25, subjects received a 2.5 mg oral dose of midazolam concurrently with the morning dose of CBD (test)"