Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

Launched by GREENCARE PHARMA · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a product called Extrato de Cannabis sativa GreenCare to understand its safety and how the body processes it. It is specifically looking for answers to whether this cannabis extract is safe for healthy adults. The trial is currently recruiting participants, and anyone interested should be between 18 and 65 years old, weigh at least 50 kg, and have a body mass index (BMI) within a normal range. Participants must also be in good health, with normal lab test results, and agree to follow the study guidelines.

If you decide to participate, you will be closely monitored to ensure your safety throughout the study. It’s important to note that certain individuals will not be eligible, including those who have recently used cannabis or other drugs, have specific mental health conditions, or are pregnant or breastfeeding. This study will help researchers gather important information about the safety of this cannabis extract, which could contribute to future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women from 18 to 65 years, inclusive;
• • 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:
• • Having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study;
• • 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.