drugset / Trial / NCT06149988
Comparative PK Study Of THC/CBD Formulations
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | THC/CBD | Unknown | 8 mg | Oral |
| Subject | THC/CBD | Unknown | 500 mg | Oral |
Indications
No indication recorded.