Spots Global Cancer Trial Database for Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

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Trial Identification

Brief Title: Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

Official Title: Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia

Study ID: NCT05272865

Conditions

Nausea Post Chemotherapy

Interventions

Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Study Description

Brief Summary: Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

Detailed Description: This evaluation project of 3 oral formulations of Δ9-THC will be carried out in two phases: Phase I evaluation of bioequivalences in healthy subjects and Phase II evaluation of safety and effectiveness comparing with the reference product (Dronabinol 5mg/mL), formulations derived from cannabis for the management of nausea, vomiting post chemotherapy and exploratory in cancer pain.