NCT04261166View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

July 24, 2019

Primary Completion Date

October 24, 2022

Study Completion Date

October 24, 2022

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)

Trial Locations (1)

13100

Ziv Medical Center, Safed

All Listed Sponsors
lead

Breath of Life International Pharma Ltd

INDUSTRY

NCT04261166 - A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract | Biotech Hunter | Biotech Hunter