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Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
Sponsor: GreenCare Pharma
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
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