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
| Name | Class |
|---|---|
| Appalachian College of Pharmacy | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.
This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This study is designed to include two arms. Each arm will be delivered a different concentration of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of the study all participants will be asked to provide four (4) plasma samples, 10 randomly selected participants will be asked to provide five (5) plasma samples. Samples will then be evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in order to determine time to reach maximum blood concentration. This trial is double-blinded with two arms enrolling only healthy individuals. The participants randomized for a fifth blood draw will be randomly selected from these two arms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg/g Full Spectrum Hemp Extract | Experimental | A single capsule of 15 mg/g Full Spectrum Hemp Extract will be delivered. |
|
| 50 mg/g Full Spectrum Hemp Extract | Experimental | A single capsule of 50 mg/g Full Spectrum Hemp Extract will be delivered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 mg/g Full Spectrum Hemp Extract | Dietary Supplement | HPMC capsules containing full spectrum standardized hemp extract in liquid form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration | To determine the time to maximum plasma concentration of cannabidiol (CBD) and cannabidiol acid (CBD-A) from an oral delivery of a single dose of standardized 15 mg or 50 mg full spectrum hemp extract | Over 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Detectable THC | To determine if the oral delivery of a full spectrum hemp extract standardized to less than 0.3% ∆^9- tetrahydrocannabinol (THC) results in detectable amounts of THC in plasma. | Over 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Present in measurable amount over time | To determine if CBD, CBD-A, or THC are present 7 to 10 days after a single oral dose of 15 mg or 50 mg standardized full spectrum hemp extract. | 7 - 10 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Appalachian College of Pharmacy | Oakwood | Virginia | 24631 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 50 mg/g Full Spectrum Hemp Extract | Dietary Supplement | HPMC capsules containing full spectrum standardized hemp extract in liquid form. |
|