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Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

NCT06807762 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-03-21

No results posted yet for this study

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?

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.

Sponsors & Collaborators

  • GreenCare Pharma

    lead INDUSTRY

Principal Investigators

  • Fernando Pacheco, MD · Synvia Clinical | CAEP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Brazil

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 NCT06807762 on ClinicalTrials.gov