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Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC

NCT05272865 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Nausea Post Chemotherapy
  • Vomiting
  • Cancer Pain
  • Cancer Related Pain
  • Neoplasms

Interventions

DRUG

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

Assessment of Pharmacokinetic and pharmacodynamic profile of THC oral formulations in 4 arms in healthy volunteers and patients post-chemotherapy.

Sponsors & Collaborators

  • LaSanta S A S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-02-15
Completion
2024-10-17

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272865 on ClinicalTrials.gov