Comparing THC/CBD powder and oil 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.
This study is testing how well a new THC/CBD powder works in the body compared to a THC/CBD oil to see which one is safer and easier to tolerate for healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | CapSoil Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Netanya) |
| Trial ID | NCT06149988 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial aims to compare the pharmacokinetics of a self-emulsified THC/CBD powder with an equivalent dose of THC/CBD oil in healthy volunteers. Participants will receive a single dose of each formulation, separated by a 30-day washout period, to assess how the body processes these substances. The study also evaluates the tolerability and safety of the self-emulsified powder compared to the oil. This crossover design allows each participant to serve as their own control, enhancing the reliability of the results.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21-65 with a cannabis license.
Not a fit: Patients with a history of allergic reactions to THC/CBD or those with underlying medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a potentially more effective and safer formulation of THC/CBD for therapeutic use.
How similar studies have performed: While there have been studies on THC/CBD formulations, this specific comparison of self-emulsified powder versus oil is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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
Where this trial is running
Netanya
- Laniado Hospital — Netanya, Israel (Recruiting)
Study contacts
- Principal investigator: Vered Hermush, M.D. — Laniado Hospital
- Study coordinator: Rafi Ezra
- Email: rafi@capsoil.com
- Phone: +972522579044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.