NCT04261166

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

A Phase I Open Label Study to Assess the Single Dose Pharmacokinetics and Safety of Sublingual Administration of Tablets and Medicated Drops of Plant Cannabis Extract

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Breath of Life International Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2019-07-24
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2020-02-07
• Last updated: 2022-12-08

Locations

1 site across 1 country: Israel