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RECRUITING
NCT06807762
PHASE1

Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

Sponsor: GreenCare Pharma

View on ClinicalTrials.gov

Summary

The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is: • Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?

Official title: Phase I Clinical Trial to Assess Tolerability, Safety, and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare 79.14 mg/mL - Drops Solution - in Healthy Research Participants of Both Sexes in a Fed State

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-03-18

Completion Date

2025-12

Last Updated

2025-03-21

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

GreenCare Pharma

Vinhedo, São Paulo, Brazil