INTERVENTIONALCOMPLETEDNCT04280289

CBD Cannabis Extract: Pharmacokinetic Studies

The initial goal is to ascertain the pharmacokinetic (PK) profile of CBD (cannabidiol) after a single dose of CBDE (cannabidiol extract), although the plan is to extend these studies to multiple dose administrations in the future, since it is likely that (cannabidiol) and/or its metabolites will show some accumulation. These studies will provide detailed information that will inform the continuation and expansion of CBDE in other research projects.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-11-20

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: EARLY PHASE1
Enrollment: 10 (ACTUAL)
Start date: 2021-02-01
Sponsor: University of Mississippi, Oxford
Design: NA · SINGLE GROUP · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

The objective is to determine the PK profile of CBD(cannabidiol) , its metabolites, and minor phytocannabinoids after single dose administration of CBDE (at 2.5 mg/kg CBD). Attainment of this goal will provide essential information on phytocannabinoid disposition and dosing regimen optimization. To accomplish this objective, the working hypothesis that complex phytochemical mixtures present in full spectrum hemp extracts (FSHEs), as exemplified by CBDE, differ from purified CBD-containing products with regard to PK, will be tested. The approach to testing this working hypothesis will be to use liquid chromatography-mass spectrometry (LC/MS) to both characterize the phytocannabinoid concentration-time profiles following CBDE administration (single and multiple dosing).

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

epilepsy

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

cannabidiol extract

The test article "CBD Cannabis Extract Oral Solution" will be manufactured by the University of Mississippi National Center for Natural Products Research (NCNPR) at the Coy Waller Laboratory under FDA Current Good Manufacturing Practices. The drug product, derived from hemp and containing less than 0.3% of Δ9-tetrahydrocannabinol, is no longer a Drug Enforcement Agency (DEA) controlled substance. DEA registrations are not required for the manufacturing, handling or dispensing of these clinical test materials

cannabidiol, CBD

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepted

Inclusion criteria

Normal, healthy adults aged 21 to 55 years

Exclusion criteria

Allergy to sesame oil/products
Obese: BMI is 35 or higher
Smoker (tobacco \& marijuana use \[smoking or use of oral hemp/CBD products\])
Currently any taking prescriptions medication(s) \[with exception of oral contraceptives\] or over-the-counter medications/supplements
Consuming botanical/non-botanical dietary supplements (3 days prior to study)
Known history of cardiac, liver, kidney or hematological disease, diabetes
Autoimmune disorders
Known history of Neurologic/Psychiatric disorders
Report of an active infection
Subject is pregnant or breast-feeding, or is expecting to conceive during the study
Subjects of child bearing potential will use (or is currently using) during the study, one of the following acceptable methods of contraception: Male sterilization (vasectomy) Female sterilization (tubal ligation, hysterectomy) Intrauterine service intrauterine device (IUD) or other implant Oral contraceptive, injectable contraceptive Contraceptive patch/ring Diaphragm Male condom Sponge/spermicide

primary outcomes

primary measures

Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).

Time frame: 0- 72 hours

This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers

Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).

Time frame: 0- 72 hours

This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers

secondary outcomes

secondary measures

Area-under-the-concentration-time profiles (AUC), and area-under-the moment curve (AUMC), for CBD (cannabidiol) , up to 72 hours after Cannabis extract administration.

Time frame: 0-72 hours

This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers

Clearance (Cl/F) up to 72 hours after Cannabis extract administration.

Current Neuropharmacology · Free full text

Snapshot provenance

Snapshot: aaa138e9-c253-419d-986e-f6e97e358fb4
Retrieved: 11/09/2026, 14:15:08
SHA-256: 43fcee220b3d87a8c3bf826f3049c2eff9d7954d653c5dc91347a953a27f68e1

CBD Cannabis Extract: Pharmacokinetic Studies

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

Researchers and organizations

What was registered

cannabidiol extract

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).

Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).

secondary measures

Area-under-the-concentration-time profiles (AUC), and area-under-the moment curve (AUMC), for CBD (cannabidiol) , up to 72 hours after Cannabis extract administration.

Clearance (Cl/F) up to 72 hours after Cannabis extract administration.

Volume of distribution (Vd),up to 72 hours after Cannabis extract administration.

Volume of distribution at steady state (Vdss),up to 72 hours after Cannabis extract administration.

Terminal elimination rate constant (ke), half-life (t1/2), up to 72 hours after Cannabis extract administration.

Mean residence time (MRT), up to 72 hours after Cannabis extract administration.

Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration.

Locally readable linked articles

Paradoxical Patterns of Sinusoidal Obstruction Syndrome-Like Liver Injury in Aged Female CD-1 Mice Triggered by Cannabidiol-Rich Cannabis Extract and Acetaminophen Co-Administration.

Hepatotoxicity of a Cannabidiol-Rich Cannabis Extract in the Mouse Model.

Corrigendum: Potential Clinical Benefits of CBD-Rich Cannabis Extracts Over Purified CBD in Treatment-Resistant Epilepsy: Observational Data Meta-analysis.

Cannabidiol Adverse Effects and Toxicity.

Time to reach Cmax (Tmax), up to 72 hours after Cannabis extract administration.