Safety and Pharmacokinetics of Extrato de Cannabis Sativa GreenCare

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

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?

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.