Completed

NCT Number: NCT07359976

Pharmacokinetic Evaluation of a Natural CBD Extract

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.

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Key information

Conditions

Pharmacokinetics of CBD Extract, Oral and Topical Administrations

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division Clinical Pharmacology, SOM, University of Utah

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

CBD extract

Dietary Supplement

The purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally.

Primary outcomes

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.

Secondary outcomes

Urine THC

Time frame: 24 hours

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.
Bioavalability

Time frame: 24 hours

To calculate the bioavailability of NHEC following topical or oral administrations using the published bioavailability data

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Pharmacokinetic Evaluation of a Natural Hemp Extract-based Cosmetic Product After Topical and Oral Application

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Jan 22, 2026
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.