Pharmacokinetics of CBD Extract, Oral and Topical AdministrationsNCT07359976
Pharmacokinetic Evaluation of a Natural CBD Extract
A study testing CBD extract in people with Pharmacokinetics of CBD Extract, Oral and Topical Administrations, run by University of Utah at 1 site in United States.
Trial summary
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of CBD Extract, Oral and Topical Administrations
- What is being tested?
- CBD extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 16 Jan 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers (males and females, 18 - 50 years old) with a BMI 19-30. Subjects who were able to ingest or apply test products. The participants understood the requirements of the study.
Who cannot join
- Individuals less than 18 years of age or over 50 years of age at enrollment;
- Individuals previously participated in a research study involving administration of the investigational compound within one month prior to the current study;
- Individuals who were using any recreational drug, specifically marijuana, in the past six months;
- Individuals with a history of alcoholism;
- Individuals who have conditions that might have possible interference with the study product absorption, distribution, metabolism, or excretion: previous surgery of the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gall bladder, pancreas or adjustable gastric band surgery, impaired glucose tolerance, diabetes mellitus, renal disease, edema, hepatic disorder.
- Individuals who are pregnant or may become pregnant during studies
- Individuals who are reporting any chronic diseases, such as mental disorders
- The University of Utah faculty, students, and employees whom the investigators of this study directly supervise
Trial locations and contacts
1 site in 1 country.
United States1 site
Division Clinical Pharmacology, SOM, University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: Pharmacokinetic Evaluation of a Natural Hemp Extract-based Cosmetic Product After Topical and Oral Application
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions.
In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.
- Being tested
- CBD extract
- Keywords
- Pharmacokinetics, CBD extract, cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD extractDietary supplement
The purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally.
| Study group | Role | What they receive |
|---|---|---|
| Oral | Active comparator | Not described Receives: Dietary Supplement: CBD extract |
| Topical | Active comparator | Not described Receives: Dietary Supplement: CBD extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of CBD, THC, and their metabolites in the plasma of participants
Since the general consumers may use oil-based CBD extract as topical cream or as a dietary supplement, this crossover study intended to characterizes the PK of the concentrations of CBD, THC, and their metabolites in the plasma of healthy volunteers receiving a single topical or oral dose of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium-chain triglycerides (MTC) derived from coconut oil.
Measured: 24 hours
Secondary outcomes (2)
Urine THC
Since the general public reports positive urine THC tests when using CBD oils, to determine whether the participants who used NHEC would have positive urine THC tests.
Measured: 24 hours
Bioavalability
To calculate the bioavailability of NHEC following topical or oral administrations using the published bioavailability data
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Jan 2021
- Primary completion7 Nov 2024
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of CBD Extract, Oral and Topical AdministrationsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Enioutina, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359976
- Sponsor's protocol ID
- 10058347
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of a Natural Hemp Extract-based Cosmetic Product After Topical and Oral Application
- ClinicalTrials.gov ID
- NCT07359976
- Acronym / sponsor ID
- 10058347
- Keywords
- Pharmacokinetics, CBD extract, cannabidiol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 22 Jan 2026 (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.
The present cross-over study investigated whether cannabidiol (CBD) or its metabolites and delta-9-tetrahydrocannabinol (THC) can be detected in the systemic circulation following a single topical application of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium chain triglycerides (capric, caprylic triglycerides or medium chain triglycerides (MCT)) derived from coconut oil. Since consumers can consider hemp/CBD oil as a nutritional product or dietary supplement, it can be ingested by consumers. Therefore, we analyzed the concentrations of CBD, THC, and their metabolites in systemic circulation after oral NHEC administration. Additionally, we tested whether a single topical or oral use of the NHEC would lead to detectable levels of THC in the urine samples using Easy@Home THC detection strips. This study has no intent to treat or prevent any diseases or conditions.
In this study, volunteer participants were assigned to one of two study groups: Cohort A (oral administration) or Cohort B (topical administration). After completing the study in the first assigned Cohort, participants had a 15-day washout period before beginning the study in the next Cohort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral | Active comparator | Dietary Supplement: CBD extract |
| Topical | Active comparator | Dietary Supplement: CBD extract |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers (males and females, 18 - 50 years old) with a BMI 19-30. Subjects who were able to ingest or apply test products. The participants understood the requirements of the study.
Key exclusion criteria (8 listed)
- Individuals less than 18 years of age or over 50 years of age at enrollment;
- Individuals previously participated in a research study involving administration of the investigational compound within one month prior to the current study;
- Individuals who were using any recreational drug, specifically marijuana, in the past six months;
- Individuals with a history of alcoholism;
- Individuals who have conditions that might have possible interference with the study product absorption, distribution, metabolism, or excretion: previous surgery of the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gall bladder, pancreas or adjustable gastric band surgery, impaired glucose tolerance, diabetes mellitus, renal disease, edema, hepatic disorder.
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 |
|---|---|---|
| CBD extractThe purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally. | Dietary supplement | Oral, Topical |
Primary outcome
Analysis of CBD, THC, and their metabolites in the plasma of participants
Time frame: 24 hours
Since the general consumers may use oil-based CBD extract as topical cream or as a dietary supplement, this crossover study intended to characterizes the PK of the concentrations of CBD, THC, and their metabolites in the plasma of healthy volunteers receiving a single topical or oral dose of a natural hemp extract-based cosmetic (NHEC) consisting of CBD and medium-chain triglycerides (MTC) derived from coconut oil.
2 secondary outcomes
Urine THC
Time frame: 24 hours
Bioavalability
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD extract in people with Pharmacokinetics of CBD Extract, Oral and Topical Administrations, run by University of Utah at 1 site in United States.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of CBD, THC, and their metabolites in the plasma of participants (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.