drugset / Trial / NCT03201835
5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
RandomizedCrossoverOpen-labelOther
Summary
The primary objective of the study was to evaluate the safety and tolerability of novel oral capsules containing THC and/or CBD, following a single administration to healthy volunteers. The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational oral formulations with Sativex® Oromucosal Spray.
Timeline
- Start
- 2015-09-24
- Primary completion
- 2015-12-06
- Completion
- 2016-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CBD | Unknown | 6.7 mg | Oral |
| Subject | CBD | Unknown | 10 mg | Oral |
| Subject | CBD | Unknown | 100 mg | Oral |
| Comparator | Nabiximols | Other / unclassified | — | Other |
| Subject | Piperine | Other / unclassified | 20 mg | — |
| Subject | THC | Unknown | 7.2 mg | Oral |
| Subject | THC | Unknown | 10.8 mg | Oral |
Indications
No indication recorded.