NCT04589455

Pharmacokinetics of CBD From a Hennep Extract

Determination of Pharmacokinetics and Food-effect of CBD From a Hennep Extract in Healthy Human Volunteers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Wageningen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Rationale: Cannabidiol (CBD) is a non-hallucinogenic plant compound of Cannabis sativa L. and has gained attention for its potential health purposes, favorable safety profile and low abuse potential. Mainly sold as food supplements, CBD-containing preparations of different composition, concentration and quality are widely available in the Netherlands via druggist stores or via Internet. However, CBD- containing preparations do not yet have a novel food status and most EU countries are currently applying a tolerance policy for CBD present in- or derived from hemp products low in THC. Likewise, there are no approved health claims for CBD, which leads to a situation that products sold by official drugstores do not contain any indication for use. Last but not least, products are not subject to any official quality control which creates a situation that consumers are unaware of the CBD content and potential contamination of the product they purchase. Getting novel food status would an important step in better regulation. Such a procedure requires a well-documented safety assessment. As part of this assessment the pharmacokinetics of CBD need to be assessed. The aim of the present study is therefore to investigate the pharmacokinetics of CBD after single oral administration of a full-spectrum hemp extract. As fatty food is reported to increase CBD oral bioavailability, we will also study the effect of a high-fat meal. Objective: To determine the pharmacokinetics of CBD following oral administration of a novel oil-based hemp extract containing 70 mg CBD and to study the effects of a high-fat meal on the oral bioavailability of CBD. Study design: Single dose randomized crossover intervention study Study population: healthy human volunteers, men and women from 18 to 60 years old with a BMI from 18 to 25 kg/m2. Intervention (if applicable): In a random order, research subjects receive a single dose of hemp extract containing 70 mg CBD in soft gel capsules, both in a fasting state and with a high-fat meal. Main study parameters/endpoints: The plasma-time curve of CBD (quantitively) and 2 of its metabolites (semi-quantitatively) after intake of the Becanex natural hemp extract. These data will be evaluated studied applying descriptive pharmacokinetic analysis (maximum peak height (Cmax), time-to-peak (Tmax), Half-life (T1/2) and area-under-the-curve (AUC)). Relative bioavailability in the fed versus fasted state will be determined by dividing individual AUC values.

Conditions

• CBD Pharmacokinetics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hennep extract	Hennep extract from Becanex containing 70 mg CBD

Timeline

• Start date: 2021-01-10
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2020-10-19
• Last updated: 2020-12-08

Locations

1 site across 1 country: Netherlands