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A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

NCT04261166 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-12-08

No results posted yet for this study

Summary

This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.

Conditions

  • Healthy

Interventions

DRUG

A1

Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)

DRUG

A2

Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)

DRUG

A3

Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)

DRUG

A4

Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)

DRUG

A5

Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)

DRUG

B1

Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)

DRUG

B2

Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)

DRUG

B3

Sublingual tablets. CBD 40 mg (1 tablet)

DRUG

B4

Sublingual tablets. CBD 40 mg (1 tablet)

Sponsors & Collaborators

  • Breath of Life International Pharma Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2022-10-24
Completion
2022-10-24

Countries

  • Israel

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 NCT04261166 on ClinicalTrials.gov