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Status unknownNCT06149988Updated Nov 29, 2023

Comparative PK Study Of THC/CBD Formulations

A Phase 1 interventional study of THC/CBD S.E powder and THC/CBD oil in Cannabis, sponsored by CapSoil. Status unknown at 1 site in Israel. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by CapSoil · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
21 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Cannabis

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Keywords

  • Powder
  • Oil
03

In context

Marijuana Abuse

530 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's planned enrollment of 14 is below the median of 60 across 431 interventional studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

This is the only study on the registry with CapSoil as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects must be 21-65 years old.
  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

Exclusion Criteria:

  1. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
  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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: THC/CBD S.E powder

  • Active comparator
    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).

    Drug: THC/CBD oil

Interventions

  • DrugTHC/CBD S.E powder

    A single dose of THC/CBD S.E powder- 500 mg, given orally.

  • DrugTHC/CBD oil

    Drug pages: Dronabinol · Cannabidiol

    Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).

06

What researchers measure

Primary outcomes

  1. To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.a) THC/CBD S.E powder and oil exposure as measured by Cmax.

    Measured by Cmax.

    Time frame: 30 days

  2. To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.b) THC/CBD S.E powder and oil exposure as measured by AUC.

    Measured by AUC.

    Time frame: 30 days

  3. To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 2. THC/CBD S.E and oil powder half life

    t1/2, should be determined by using model independent analytical methods.

    Time frame: 30 days

  4. To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 3. THC/CBD S.E powder and oil onset of action and time to reach maximum blood concentration as measured by Tmax.

    Measured by Tmax.

    Time frame: 30 days

Secondary outcomes

  1. To demonstrate that the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil: Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).

    By tracking Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).

    Time frame: though study completion, 30 days

Other outcomes

  1. Minimum blood concentration (Cmin)

    Cmin, by using model independent analytical methods.

    Time frame: though study completion, 30 days

  2. Bioavailability

    By using model independent analytical methods.

    Time frame: though study completion, 30 days

07

Study locations

1 of 1 sites recruiting
  • Laniado Hospital
    Netanya, 42150, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06149988
Lead sponsor
CapSoil
Responsible party
Sponsor
First posted
Nov 29, 2023
Start date
Aug 27, 2023
Primary completion
Feb 1, 2024 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Nov 29, 2023

Study contacts

Rafi Ezra
Contact
rafi@capsoil.com
+972522579044
Shimrit Tradion
Contact
shimrit@capsoil.com
+972509303335
Vered Hermush, M.D.
principal investigator · Laniado Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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