drugset / Trial / NCT06149988

Comparative PK Study Of THC/CBD Formulations

NCT06149988 ↗

Phase 1 Unknown 14 enrolled CapSoil
Non-randomizedCrossoverOpen-labelTreatment

Summary

A phase I, single center crossover study. The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers. The main question it aims to answer is: •If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose). The secondary is: •If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil. Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.

Timeline

Start
2023-08-27
Primary completion
2024-02-01
Completion
2024-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator THC/CBD Unknown 8 mg Oral
Subject THC/CBD Unknown 500 mg Oral

Indications

No indication recorded.