CBD PharmacokineticsNCT04589455
Pharmacokinetics of CBD From a Hennep Extract
A study testing Hennep extract in people with CBD Pharmacokinetics, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CBD Pharmacokinetics
- What is being tested?
- Hennep extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jan 2021to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18,5 and 25 kg/m2
- Age between 18 and 60 years
- Weight above 50 kg
- Good general health (based on general health questionnaire)
- Veins suitable for blood sampling
- Able to speak Dutch
- Pertinent willingness to abstain from using any hemp product (including recreational Cannabis) 2 weeks prior and the entire study period.
Who cannot join
- Is currently suffering from a disease
- Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
- Haemoglobin (Hb) level < 8.5 mmol/L for men and < 7.5 for women
- Has used medication in the two months before and/or during the intervention. Oral contraceptives and occasional use of NSAIDs or paracetamol (<max 3 a week on average) is allowed.
- Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
- Use of herbal dietary supplements (excluding vitamins and minerals) or grapefruit products, 2 weeks before the first testday and in between the testdays.
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- Allergic to products that are provided as part of the standardised diet
- Following a specific diet (e.g. vegetarian, gluten free)
- (History of) drug abuse, in this case meaning >1 x per month use of recreational drugs
- Cannabis use in the 14 days preceding the first test day.
- Smoking
- Alcohol consumption of >10 standardised glasses per week.
- Recent or planned blood donation (<3 month prior to first study day or during intervention)
- Have been pregnant or breastfeeding in the last 6 months, or plan to become pregnant during the study
- (If applicable) In case of using contraceptives, not willing to delay the break between two packets of the conception pill during which a woman gets her period during the study period.
- Personnel of Wageningen University, department of Human Nutrition and Health,
- Currently participating in other research or was participating in another study within 1 month of the intervention or within 3 months if invasive procedures were used.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen
Wout van Orten-Luiten, MSc, +31317-481100, wout.vanorten-luiten@wur.nl
About this study
Official title: Determination of Pharmacokinetics and Food-effect of CBD From a Hennep Extract in Healthy Human Volunteers
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.
Read more
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
- Being tested
- Hennep extract
- Keywords
- CBD, pharmacokinetics, hennep extract, food-effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hennep extractDietary supplement
Hennep extract from Becanex containing 70 mg CBD
| Study group | Role | What they receive |
|---|---|---|
| hennep extract | Experimental | A hennep extract administered in soft gel capsules in a fasted state Receives: Dietary Supplement: Hennep extract |
| hennep extract + high fat meal | Experimental | A hennep extract administered in soft gel capsules in a fed state Receives: Dietary Supplement: Hennep extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of CBD in a fed versus a fasted state
Relative bioavailability will be calculated by dividing individual AUC values
Measured: 48 hours
Area under the curve (AUC)
Area under the curve of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Measured: 48 hours
Maximum concentration (Cmax)
Maximum concentration of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Measured: 48 hours
Time to peak (Tmax)
Time to peak of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Measured: 48 hours
Half life (t1/2)
Half life of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Measured: 48 hours
Secondary outcomes (4)
Area under the curve (AUC)
Area under the curve of plasma CBD concentration after intake of a hemp extract, compared between men and women
Measured: 48 hours
Maximum concentration (Cmax)
Maximum concentration of plasma CBD concentration after intake of a hemp extract compared between men and women
Measured: 48 hours
Time to peak (Tmax)
Time to peak of plasma CBD concentration after intake of a hemp extract compared between men and women
Measured: 48 hours
Half life (t1/2)
Half life of plasma CBD concentration after intake of a hemp extract compared between men and women
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start10 Jan 2021 (estimated)
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CBD PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Becanex
- Responsible party
- Sponsor
- Investigators
- Ringer Witkamp, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589455
- Sponsor's protocol ID
- NL74963.081.20
- Status last verified
- Oct 2020
- First submitted
- 6 Aug 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saals BADF, De Bie TH, Osmanoglou E, van de Laar T, Tuin AW, van Orten-Luiten ACB, Witkamp RF. A high-fat meal significantly impacts the bioavailability and biphasic absorption of cannabidiol (CBD) from a CBD-rich extract in men and women. Sci Rep. 2025 Jan 29;15(1):3678. doi: 10.1038/s41598-025-87621-4.
PubMed 39880884
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Pharmacokinetics and Food-effect of CBD From a Hennep Extract in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT04589455
- Acronym / sponsor ID
- NL74963.081.20
- Conditions
- CBD Pharmacokinetics
- Keywords
- CBD, pharmacokinetics, hennep extract, food-effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Becanex
- Study start
- 10 Jan 2021 (estimated)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Mar 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hennep extract | Experimental | Dietary Supplement: Hennep extractA hennep extract administered in soft gel capsules in a fasted state |
| hennep extract + high fat meal | Experimental | Dietary Supplement: Hennep extractA hennep extract administered in soft gel capsules in a fed state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI between 18,5 and 25 kg/m2
- Age between 18 and 60 years
- Weight above 50 kg
- Good general health (based on general health questionnaire)
- Veins suitable for blood sampling
Key exclusion criteria (17 listed)
- Is currently suffering from a disease
- Has had any gastrointestinal condition/disease within the 3 months prior to the intervention
- Haemoglobin (Hb) level < 8.5 mmol/L for men and < 7.5 for women
- Has used medication in the two months before and/or during the intervention. Oral contraceptives and occasional use of NSAIDs or paracetamol (<max 3 a week on average) is allowed.
- Reported weight loss or weight gain of > 2 kg in the month prior to the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hennep extractHennep extract from Becanex containing 70 mg CBD | Dietary supplement | hennep extract, hennep extract + high fat meal |
Primary outcome
Relative bioavailability of CBD in a fed versus a fasted state
Time frame: 48 hours
Relative bioavailability will be calculated by dividing individual AUC values
Area under the curve (AUC)
Time frame: 48 hours
Area under the curve of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Maximum concentration (Cmax)
Time frame: 48 hours
Maximum concentration of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Time to peak (Tmax)
Time frame: 48 hours
Time to peak of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
Half life (t1/2)
Time frame: 48 hours
Half life of plasma CBD concentration after intake of a hemp extract in a fed and fasted state
4 secondary outcomes
Area under the curve (AUC)
Time frame: 48 hours
Maximum concentration (Cmax)
Time frame: 48 hours
Time to peak (Tmax)
Time frame: 48 hours
Half life (t1/2)
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 39880884Saals BADF, De Bie TH, Osmanoglou E, van de Laar T, Tuin AW, van Orten-Luiten ACB, Witkamp RF. A high-fat meal significantly impacts the bioavailability and biphasic absorption of cannabidiol (CBD) from a CBD-rich extract in men and women. Sci Rep. 2025 Jan 29;15(1):3678. doi: 10.1038/s41598-025-87621-4.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ringer Witkamp, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hennep extract in people with CBD Pharmacokinetics, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wout van Orten-Luiten, MSc (+31317486352, wout.vanorten-luiten@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative bioavailability of CBD in a fed versus a fasted state (time frame: 48 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.