MedTrace Logo

Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers

NCT03936907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-24

No results posted yet for this study

Summary

This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.

Conditions

  • Healthy Subjects

Interventions

DRUG

OWCP Orally Disintegrating Tablet

Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD

DRUG

Sativex

Sativex® Oromucosal Spray

Sponsors & Collaborators

  • One World Cannabis Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-07-18
Completion
2019-07-18

Countries

  • Israel

Study Locations

More Related Trials

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 NCT03936907 on ClinicalTrials.gov