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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of THC/CBD S.E powder | Experimental | On visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally. |
|
| a single dose of THC/CBD oil | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC/CBD S.E powder | Drug | A single dose of THC/CBD S.E powder- 500 mg, given orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| 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. | 30 days |
| 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. | 30 days |
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | though study completion, 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum blood concentration (Cmin) | Cmin, by using model independent analytical methods. | though study completion, 30 days |
| Bioavailability | By using model independent analytical methods. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafi Ezra | Contact | +972522579044 | rafi@capsoil.com | |
| Shimrit Tradion | Contact | +972509303335 | shimrit@capsoil.com |
| Name | Affiliation | Role |
|---|---|---|
| Vered Hermush, M.D. | Laniado Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laniado Hospital | Recruiting | Netanya | 42150 | Israel |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| THC/CBD oil | Drug | Followed by a 30-day washout- A single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder). |
|
| though study completion, 30 days |