A Single-Center, Randomized, 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

Exclusion criteria

• 1. Known hypersensitivity to cannabinoids (including cannabis extracts), excipients or capsules. 2. Any history of adverse events associated with cannabis intoxication or dependence. 3. Known/suspected history or family history of psychiatric disorders 4. History of fainting or recurrent dizziness 5. History of epilepsy/seizures. 6. Documented history or ongoing symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease. 7. History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders). 8. Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications. 9. Presence of mouth ulcerations or any abnormalities of the oral cavity. 10. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit. 11. Used cannabinoids or a cannabinoid-based medicine within 30 days prior to receiving study medication. 12. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to anticipated first dosing; subjects who had treatment with any known enzyme-altering agent (e.g. CYP450 inducers or inhibitors), within 30 days of first dosing. Paracetamol or for symptomatic relief of pain is allowed until 24 hours prior to first study drug administration. 13. Known drug hypersensitivity or history of idiosyncratic reactions to any drug. 14. Subjects with an abnormal diet, who had made substantial changes to eating habits within 30 days of the study, 15. History of drug or alcohol abuse in the last two years. 16. Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration that is considered of significance by the investigator. 17. Participation in another clinical trial with drugs received within 3 months prior to first dosing (calculated from the previous study's last dosing date). 18. Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration. 19. Subjects who refuse to avoid strenuous physical activity within 48 hours prior to each drug administration and throughout in-house stay in the CRC. 20. Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function). 21. Subjects who are non-cooperative or unwilling to sign informed consent form.