Status:
UNKNOWN
Comparative PK Study Of THC/CBD Formulations
Lead Sponsor:
CapSoil
Conditions:
Cannabis
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Subjects must be 21-65 years old.
- Subjects must have a signed study informed consent before any procedure.
- 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.
- 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
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
- Has an underlying medical condition that would preclude study participation.
- Chronic use of medications for underlying medical conditions.
- Use of any medications within 24 hours prior to treatment visit.
- Is currently participating in another study of an investigational agent/medical device.
- Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
- Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
- Patients who previously suffered from depression or anxiety.
- Medical history of high blood pressure, low blood pressure or diabetes.
- Patients who experience difficulties in performing daily activities.
- Current cannabis use or positive THC urine test results.
- Pregnant or lactating female subjects
Key Trial Info
Start Date :
August 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06149988
Start Date
August 27 2023
End Date
February 1 2024
Last Update
November 29 2023
Active Locations (1)
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1
Laniado Hospital
Netanya, Israel, 42150