NCT05076890

Hemp 15 mg & 50 mg Capsule Absorption

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Gaia Herbs Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Absorption; Chemicals

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	15 mg/g Full Spectrum Hemp Extract	HPMC capsules containing full spectrum standardized hemp extract in liquid form.
DIETARY_SUPPLEMENT	50 mg/g Full Spectrum Hemp Extract	HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Timeline

• Start date: 2021-08-26
• Primary completion: 2022-03-26
• Completion: 2022-03-26
• First posted: 2021-10-13
• Last updated: 2023-02-28

Locations

1 site across 1 country: United States