NCT06149988

Comparative PK Study Of THC/CBD Formulations

A Phase I, Single Center Crossover Study, Evaluating the Pharmacokinetic Profile and Safety of Self-emulsified THC/CBD Powder Compared With Equivalent Dose of THC/CBD Oil, Orally Administered.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: CapSoil · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A phase I, single center crossover study. The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers. The main question it aims to answer is: •If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose). The secondary is: •If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil. Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.

Conditions

• Cannabis

Interventions

Type	Name	Description
DRUG	THC/CBD S.E powder	A single dose of THC/CBD S.E powder- 500 mg, given orally.
DRUG	THC/CBD oil	Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).

Timeline

• Start date: 2023-08-27
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-11-29
• Last updated: 2023-11-29

Locations

1 site across 1 country: Israel