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A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

NCT06578455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-17

No results posted yet for this study

Summary

Cannabidiol (CBD), derived from the Cannabis sativa plant, is being investigated for its potential health benefit without the psychoactive properties and adverse reactions that arise from the use of delta-9-tetrahydrocannabinol (Δ9-THC). Few studies have characterized the pharmacokinetic (PK) effects and safety of oral CBD administration. Epidiolex (Epidyolex), an oil form of CBD, is the only marketed monotherapy approved by the United States Food and Drug Administration (FDA) and Health Canada. Delivery of a CBD in a powder/capsule form may provide a more efficient method for consumers.

The goal of this study is to characterize the PK profile of the test product, CBD-NE (a capsule formulation) compared to Epidyolex under both fasted and fed conditions. Each participant will receive a dose of each product under both fed and fasted conditions in a crossover design.

Conditions

  • CBD Pharmacokinetics
  • Healthy Participants

Interventions

DRUG

Cannabidiol (CBD) Powder

66.68 mg CBD per capsule for a total of 400 mg CBD per serving

DRUG

Cannabidiol 100 MG/ML [Epidiolex]

100 mg CBD/mL for a total of 400 mg CBD per serving

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony Bier, MD · Apex Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2024-11-20
Completion
2024-12-16

Countries

  • Canada

Study Locations

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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 NCT06578455 on ClinicalTrials.gov