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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?
Details
| Lead sponsor | GreenCare Pharma |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 72 |
| Start date | 2025-03-18 |
| Completion | 2025-12 |
Conditions
- Healthy
Interventions
- Cannabis oil
Primary outcomes
- Identification of the Maximum Tolerated Dose (MTD) of Cannabis sativa Extract GreenCare 79,14 mg/mL — Up to 5 days
Countries
Brazil