Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental | Single dose in fasted state of : A1, A2,A3, A4, A5, B1, B2, B3, B4 |
|
| Cross-Over food effect | Experimental | 2 doses: fasted and fed state with the same product: A1, A4, A5, B4 |
|
| Cross-Over product comparison | Experimental | 2 doses: in fasted state comparing A1 to A4 |
|
| Cross-over route of administration comparison | Experimental | 2 doses: in fasted state comparing oral administration to sublingual administration of A4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A1 | Drug | Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis of Cmax | 0-12 hours post dose | |
| Pharmacokinetic analysis of Tlag | 0-12 hours post dose | |
| Pharmacokinetic analysis of Tmax | 0-12 hours post dose | |
| Pharmacokinetic analysis of AUC(0-t) | 0-12 hours post dose | |
| Pharmacokinetic analysis of AUC(0-∞) | 0-12 hours post dose | |
| Pharmacokinetic analysis of %AUC extrapolated | 0-12 hours post dose | |
| Pharmacokinetic analysis of T1/2 | 0-12 hours post dose | |
| Pharmacokinetic analysis of clearance from plasma (Cl/F) | 0-12 hours post dose | |
| Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F) | 0-12 hours post dose | |
| Pharmacokinetic analysis of clearance from plasma dose normalized Cmax | 0-12 hours post dose | |
| Pharmacokinetic analysis of dose normalized AUC |
Not provided
Not provided
Inclusion Criteria:
Healthy, male or female, between 18 and 45 years of age (inclusive).
Body mass index (BMI) between 20-30 kg/m2 (both inclusive)
No recent cannabis usage within 30 days from screening
Normal rage hepatic functions
No electrolytes abnormalities
Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziv Medical Center | Safed | 13100 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C053396 | L 644711 |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| A2 | Drug | Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop) |
|
|
| A3 | Drug | Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop) |
|
|
| A4 | Drug | Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops) |
|
|
| A5 | Drug | Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop) |
|
|
| B1 | Drug | Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet) |
|
|
| B2 | Drug | Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet) |
|
|
| B3 | Drug | Sublingual tablets. CBD 40 mg (1 tablet) |
|
|
| B4 | Drug | Sublingual tablets. CBD 40 mg (1 tablet) |
|
|
| 0-12 hours post dose |