Actively Recruiting
Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
Led by GreenCare Pharma · Updated on 2025-03-21
72
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women from 18 to 65 years, inclusive
- Body weight 63 50 kg and BMI between 18.5 and 30 kg/m2, inclusive
- Be healthy according to medical history, with laboratory test results within normal ranges or clinically insignificant deviations
- Exclusively participate in this clinical study during the research period
- Understand and agree to the protocol requirements by signing the approved Informed Consent Form
You will not qualify if you...
- Participated in any experimental study or used any experimental drug within 1 year before this study
- Unable to take oral medication or cooperate with investigators due to cognitive or mental issues
- Allergy to any component of Cannabis sativa extract 79.14 mg/mL
- Personal or family history of schizophrenia, bipolar disorder, psychotic symptoms, suicidal thoughts or attempts, or severe uncontrolled psychiatric conditions
- Donated blood within 4 months before signing the Informed Consent Form
- Pregnant, breastfeeding, planning pregnancy during the study, or positive urinary b2-HCG test
- Used Cannabis or its derivatives within the past 6 months
- Personal history of Cannabis or other illicit drug use disorders
- History of alcohol, tobacco, opioid, benzodiazepine, barbiturate, or other substance use disorders
- Smokers or ex-smokers who quit less than 6 months ago
- Consumed alcohol within 24 hours before study confinement
- Any condition or dietary habit that prevents participation or ingestion of the study diet
- Any clinical or lab findings or therapy that may risk the participant or interfere with study objectives
- Non-compliance with the complete ingestion of the provided diet as determined by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GreenCare Pharma
Vinhedo, São Paulo, Brazil, 13288006
Actively Recruiting
Research Team
F
Fabio Furtado
CONTACT
H
Helena Joaquim, MsC, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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