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Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations

NCT03877991 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CBD-sesame oil capsule

A capsule containing cannabidiol dissolved in sesame oil and surfactant vehicle.

DRUG

CBD-LNL capsule

A capsule containing Cannabidiol dissolved in self nano emulsifying formulation

DRUG

CBD powder form capsule

Powder of Cannabidiol filled in a hard gelatin capsule, without formulation.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Elyad Davidson, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2025-02-19
Completion
2025-02-19

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877991 on ClinicalTrials.gov