Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Healthy
Interventions
DRUG

Cannabis oil

"Healthy subjects will be treated with a solution of Cannabis sativa extract diluted in MCT oil, at doses ranging from 39.62 mg to 791.4 mg. This protocol will be divided into two stages:~Stage 1 - Determination of the Maximum Tolerated Dose (MTD): Participants (n=60) will be dynamically randomized and will receive Cannabis sativa extract (GreenCare, 79.14 mg/mL) as a single dose after breakfast, with doses ranging from 39.62 mg to 791.4 mg.~Stage 2 - Assessment of the MTD: All participants (n=12) will receive the MTD determined in Stage 1, administered in two daily doses for 14 consecutive days."

Trial Locations (1)

13288006

RECRUITING

GreenCare Pharma, Vinhedo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GreenCare Pharma

INDUSTRY