Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2023-08-27
2024-02-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Single dose of THC/CBD S.E powder
On visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally.
THC/CBD S.E powder
A single dose of THC/CBD S.E powder- 500 mg, given orally.
a single dose of THC/CBD oil
On visit 2 (30 days later): Subjects will receive a single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).
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).
Interventions
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THC/CBD S.E powder
A single dose of THC/CBD S.E powder- 500 mg, given orally.
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).
Eligibility Criteria
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Inclusion Criteria
2. Subjects must have a signed study informed consent before any procedure.
3. Subjects must have a cannabis license as detailed at procedure No. 106 of the IMC-GCO , license will be issued and approved by PI at screening visit after signing on informed consent.
4. Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine pregnancy test at screening, visit 1 and visit 2.
Exclusion Criteria
2. Has an underlying medical condition that would preclude study participation.
3. Chronic use of medications for underlying medical conditions.
4. Use of any medications within 24 hours prior to treatment visit.
5. Is currently participating in another study of an investigational agent/medical device.
6. Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
7. Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
8. Patients who previously suffered from depression or anxiety.
9. Medical history of high blood pressure, low blood pressure or diabetes.
10. Patients who experience difficulties in performing daily activities.
11. Current cannabis use or positive THC urine test results.
12. Pregnant or lactating female subjects
21 Years
65 Years
ALL
Yes
Sponsors
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CapSoil
OTHER
Responsible Party
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Principal Investigators
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Vered Hermush, M.D.
Role: PRINCIPAL_INVESTIGATOR
Laniado Hospital
Locations
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Laniado Hospital
Netanya, , Israel
Countries
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Central Contacts
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Facility Contacts
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Vered Hermush, M.D.
Role: primary
Other Identifiers
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V1022022
Identifier Type: -
Identifier Source: org_study_id