drugset / Trial / NCT03936907
Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.
Timeline
- Start
- 2019-04-15
- Primary completion
- 2019-07-18
- Completion
- 2019-07-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 5 mg | Other |
| Subject | Dronabinol | Other / unclassified | 5 mg | Other |
| Subject | Dronabinol | Other / unclassified | 5.4 mg | Other |
Indications
No indication recorded.