- Natural product: Cannabis (Cannabis sativa)
- Associated study: Drug Approval Package: Epidiolex (Cannabidiol)
In Vivo Interaction Study
CBD Effect on Midazolam
No Effect (based on bioequivalence limits) was detected.
midazolam 708298
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
Females
Healthy volunteers
Males
16
Predose; 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 14, 18, 24 h
Drug or Natural Product Administration
Oral
Solution
2.5 mg
Once
Once
Oral
Solution
escalating dosing until 750 mg
BID
25 days
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)"