Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574100
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management
Detailed Description:
Cannabis formulations are typically administered by the oral route of administration This route represents the most common administration route for most pharmaceuticals due to the ease of administration and convenience Inhalational products are not acceptable for the sports athlete population due to potential damage to lung tissues Topical products do not have adequate bioavailability to meet our therapeutic objectives Our PK studies then need to employ the same dosage form and route of administration we expect to use in future clinical efficacy trials
Given the low bioavailability expected with CBD oral formulations we wish to assess two different formulations and the relative extent of CBD absorption Our future planned CBD intervention studies in athletes will require use of larger doses of CBD The formulation with the larger bioavailability will help to reduce the overall size of the dose utilized and therefore reduce the amount of product exposure in our clinical intervention studies This will increase the likelihood that a Cannabis company can supply the necessary amount of product and reduce the overall cost associated with the studies Generally speaking based on current literature published around CBD administration for therapeutic application higher doses of CBD ie 50mgkgd were found to correlate to more positive outcomes than lower doses ie 1mgkgd Assuming an average weight of 70 kg a 1000 mg dose would be around 1429 mgkg and a 3000 mg dose around 4286 mgkg This will allow us to investigate the pharmacokinetics of CBD on both ends of the hypothetical efficacy trend Studies have examined single orally administered doses up to 6000 mg with no serious adverse effects reported
Given the low bioavailability expected with CBD oral formulations we wish to assess two different formulations and the relative extent of CBD absorption Our future planned CBD intervention studies in athletes will require use of larger doses of CBD The formulation with the larger bioavailability will help to reduce the overall size of the dose utilized and therefore reduce the amount of product exposure in our clinical intervention studies This will increase the likelihood that a Cannabis company can supply the necessary amount of product and reduce the overall cost associated with the studies Generally speaking based on current literature published around CBD administration for therapeutic application higher doses of CBD ie 50mgkgd were found to correlate to more positive outcomes than lower doses ie 1mgkgd Assuming an average weight of 70 kg a 1000 mg dose would be around 1429 mgkg and a 3000 mg dose around 4286 mgkg This will allow us to investigate the pharmacokinetics of CBD on both ends of the hypothetical efficacy trend Studies have examined single orally administered doses up to 6000 mg with no serious adverse effects reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None