Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare
NCT ID: NCT06807762
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-03-18
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Cannabis on Male Reproductive Functions
NCT06755346
Creatine Kinase Levels and Clinical and Functional Parameters in Parajiu-jitsu Athletes
NCT03698578
Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury
NCT04586712
Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women
NCT05820321
Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals
NCT03820245
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extrato de Cannabis sativa GreenCare 79.14 mg/mL
Concentration unit: 79.14 mg/mL
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body weight ≥ 50 kg and BMI between 18.5 and 30 kg/m2, inclusive;
* Be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant;
* Be exclusively participating in this clinical study during the research period;
* Understand and comply with the protocol requirements and consent to participate in the study by signing the Informed Consent Form (ICF) approved by an Ethics Committee (EC).
Exclusion Criteria
* Inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state;
* Reported allergy to any component of Cannabis sativa extract 79.14 mg/mL;
* Personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator;
* Donated blood within four (4) months prior to signing the Informed Consent Form (ICF);
* Being pregnant, breastfeeding, intending to become pregnant during the study period, or having a positive result for urinary β-HCG testing;
* Reported use of Cannabis and/or its derivatives for any purpose in the past 6 months;
* Personal history of Cannabis use disorder and/or other illicit drug use disorder;
* Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate, and/or other substance use disorders, such as St. John's Wort;
* Smokers or ex-smokers who quit less than 6 months ago;
* Consumed alcoholic beverages within 24 hours before the study confinement period;
* Any condition that prevents participation at the discretion of the investigator;
* Dietary habits that prevent ingestion of the diet provided during the study;
* Any clinical or laboratory finding or therapy that, at the investigator's discretion, may place the participant at risk or interfere with study objectives or outcomes;
* Non-compliance with the complete ingestion of the diet provided - determination at the discretion of the responsible physician.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GreenCare Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fernando Pacheco, MD
Role: PRINCIPAL_INVESTIGATOR
Synvia Clinical | CAEP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GreenCare Pharma
Vinhedo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
131.001.23
Identifier Type: OTHER
Identifier Source: secondary_id
GreenCare-ExtratoCannabis-0124
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.