Actively Recruiting
Phase 1 Study of Safety and How the Body Processes Extrato de Cannabis sativa GreenCare 79.14 mgmL Drops in Healthy Adults
Led by GreenCare Pharma · Updated on 2025-03-21
72
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to evaluate the pharmacokinetic availability, safety, and tolerability of Extrato de Cannabis sativa GreenCare 79.14 mgmL in healthy adults aged 18 to 65. The main goal is to determine if this cannabis extract is safe when taken by healthy volunteers. This study is sponsored by GreenCare Pharma and focuses on healthy participants without significant medical issues. The study involves administering a cannabis oil solution containing the extract in doses ranging from 39.62 mg to 791.4 mg. The trial is divided into two stages Stage 1 will identify the maximum tolerated dose MTD with a single dose after breakfast in 60 participants. Stage 2 will assess the MTD by giving 12 participants two daily doses for 14 consecutive days. The cannabis extract is diluted in MCT oil and given as drops. Participants will be monitored closely during the study, which lasts up to 5 days for the primary outcome and 14 days for the extended dosing stage. Researchers will collect data on adverse events, plasma concentrations of CBD and THC, and safety measures. The study requires participants to follow a specific diet and comply with study procedures. Safety and tolerability will be evaluated through clinical and laboratory assessments throughout the dosing period.
CONDITIONS
Brief Title
Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
Research Team
F
Fabio Furtado
H
Helena Joaquim, MsC, PhD
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