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Comparative PK Study Of THC/CBD Formulations

NCT06149988 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-11-29

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • CapSoil

    lead OTHER

Principal Investigators

  • Vered Hermush, M.D. · Laniado Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-27
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149988 on ClinicalTrials.gov