Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations
1 other identifier
interventional
12
1 country
1
Brief Summary
The oral bio-availability of cannabidiol (CBD) is low due to poor water solubility and susceptibility to extensive first pass metabolism, resulting in relative bio-availability of 6%.This project is designed to evaluate the plasma concentration vs. time profile of a self emulsifying drug delivery system termed Long Chain Nano Lipospheres (LNL) for enhancing the oral bio-availability of cannabidiol (CBD). The main goal of this study is to evaluate the bio-equivalence of CBD in the LNL product, compared to CBD in a sesame oil vehicle and CBD without any formulation, in powder form. Bio-equivalence is measured by AUC 0-24h, Tmax and Cmax.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 pain
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 18, 2019
CompletedStudy Start
First participant enrolled
February 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2025
CompletedJuly 11, 2024
February 1, 2024
1 year
March 14, 2019
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters of CBD
Assesment of the pharmacokinetic profile of Cannabidiol in healthy volunteers. Plasma concentrations will be determined using HPLC-MS/MS validiated assay. The unit of measure will be provided as ng/ml.
24 Hours
Secondary Outcomes (3)
Exposure to the metabolites of the study drugs
24 hours
Measurement of pharmacodynamic (PD) variables following CBD administration
24 hours
Measurment of reaction time and coordination following CBD administration.
24 hours
Study Arms (3)
CBD-sesame oil capsule
EXPERIMENTAL12 volunteers will receive a single oral dose of CBD in a sesame oil vehicle filled in a capsule, with 200 mL of water. The dose of CBD to be administrated is 90 mg.
CBD-LNL capsule
EXPERIMENTAL12 volunteers will receive a single oral dose of CBD-LNL formulation filled in a capsule, with 200 mL of water. The dose of CBD to be administrated is 90 mg.
CBD powder form capsule
EXPERIMENTAL12 volunteers will receive a single oral dose of CBD in powder form filled in a hard gelatin capsule, with 200 mL of water. The dose of CBD to be administrated is 90 mg.
Interventions
A capsule containing cannabidiol dissolved in sesame oil and surfactant vehicle.
A capsule containing Cannabidiol dissolved in self nano emulsifying formulation
Powder of Cannabidiol filled in a hard gelatin capsule, without formulation.
Eligibility Criteria
You may qualify if:
- \. Men 18 through 45 years of age with body mass index in the range of: 19 through 30 kg/m2.
- \. Participants should be able to ingest and absorb oral medications.
- \. Subjects must be in good health as determined by medical history, vital signs measurements, physical examination (routine examination performed by the general physician), and clinical laboratory tests (blood count and biochemistry conducted in the Health maintenance organization in Israel( "kupat holim").
- \. Potential participants will undergo a screening/explanatory interview in which their compatibility will be examined. The screening interview will be held prior to the first day of trial (at least during the near month preceding the first day of trial).
- \. Subjects must be able to understand and comply with the requirements of the study (e.g. all medication, dietary, and alcohol restrictions).
- \. Subjects must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator.
- \. Subjects must complete the screening process within 4 weeks prior to the admission visit.
You may not qualify if:
- Previous participation in an research trial involving administration of any of the investigated compounds within one month prior to the current study.
- The subject is suffering from, or has a clinically significant history of, one or more of the following: impaired glucose tolerance, diabetes mellitus, renal disease, edema, stroke or neurological disorder, rheumatological disorder (including arthritis, joint or tendon abnormalities), pulmonary disorder (including a personal history of asthma, but excluding resolved pediatric asthma), hepatic disorder, has a personal history of seizures, history of psychosis any addictive or other psychiatric disease disorder or a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject by participation in the study.
- The subject has a known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 or 2.
- Any history of adverse events associated with cannabis intoxication or dependence.
- A subject that has used one of the forbidden drugs, substances or foods as follows:
- Any investigational product (THC or/and CBD ingestion or smoking) within one month preceding the study.
- Any prescription or non-prescription medication (including herbal remedies, vitamins or dietary supplements) or vaccine within 14 days of the first day of study drug administration (Day 1) or within 5 half-lives before the first day of study drug administration, whichever is longer.
- Exceptions are locally acting medications (eg, topical creams), which are not allowed within 5 days of study drug administration, and the occasional use of acetaminophen (up to 3 g/day) and ibuprofen (up to 1200 mg/day).
- Consumption of grapefruit, grapefruit juice, Seville oranges, pomelo containing products, within the 14 days prior to Day -1 and then throughout the entire study.
- Consumption of excessive amounts of alcoholic beverages, defined as \>3 drinks per day (beer, wine, or distilled spirits), or unwilling to comply with the restricted use of alcohol during the study (48 hours prior to admission and throughout the study), who have history of alcoholism.
- Subject that has any condition that may possibly interfere with drug absorption, distribution, metabolism, or excretion (eg, previous surgery on the gastrointestinal tract \[including removal of parts of stomach, bowel, liver, gall bladder, or pancreas\] or stomach banding).
- Exhausting physical exercise 48 hours prior to drug administration.
- The subject does not agree to abstain from excessive caffeine and xanthine containing foods and beverages (ie, equivalent to \>4 cups brewed coffee per day) from 48hr prior to Day -1 and throughout the entire study.
- Those who had donated \>0.5 L blood within 30 days of study.
- Abnormal blood pressure and heart rate values according to the following criteria:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 9112001, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elyad Davidson, MD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 18, 2019
Study Start
February 19, 2024
Primary Completion
February 19, 2025
Study Completion
February 19, 2025
Last Updated
July 11, 2024
Record last verified: 2024-02