Pharmacokinetic Evaluation of a Natural CBD Extract

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics of CBD Extract, Oral and Topical Administrations
• Intervention / Treatment: Dietary supplement: CBD extract

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Division Clinical Pharmacology, SOM, University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

1. Individuals less than 18 years of age or over 50 years of age at enrollment;
2. Individuals previously participated in a research study involving administration of the investigational compound within one month prior to the current study;
3. Individuals who were using any recreational drug, specifically marijuana, in the past six months;
4. Individuals with a history of alcoholism;
5. 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.
6. Individuals who are pregnant or may become pregnant during studies
7. Individuals who are reporting any chronic diseases, such as mental disorders
8. The University of Utah faculty, students, and employees whom the investigators of this study directly supervise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral	Dietary supplement: CBD extract; The purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally.
Active Comparator: Topical	Dietary supplement: CBD extract; The purified CBD extract dissolved in the medium-chain coconut oil was administered by participants topically or orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
Bioavalability	To calculate the bioavailability of NHEC following topical or oral administrations using the published bioavailability data	24 hours

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): January 16, 2025

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; cannabidiol; CBD extract
• Other Study ID Numbers: 10058347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No