A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers

Exclusion criteria

• Known history of significant medical disorders including: cardiac, gastroenterological, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal (or other) that, as per the medical judgment of the principal investigator, could interfere with the execution and/or results of the study or contraindicates administration of the study medications.
• History of fainting or recurrent dizziness.
• History of epilepsy/seizures.
• History of any significant psychiatric disorder i.e., mania, depression, or schizophrenia.
• Any known or suspected history or family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than reactive depression.
• Known hypersensitivity to cannabinoids (including cannabis extracts), excipients of tablet or of Sativex.
• Any history of cannabis dependence.
• Any history of adverse events associated with cannabis intoxication.
• A history of drug or alcohol abuse, or a history of regular alcohol consumption (by declaration) within 6 months of the study, defined as an average weekly intake of \>14 drinks. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. Positive urine drug of abuse test on Screening and on admission to the CRC before dosing.
• A positive alcohol breath test on admission to the CRC before dosing.
• History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis).
• Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at the Screening visit.
• Liver disease or liver injury manifested by clinically significant abnormal liver function tests
• Subjects receiving concomitant antipsychotic, sedative, hypnotic or other psychoactive drugs.
• Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements including St. John's Wort within 14 days prior to anticipated dosing; subjects who had treatment with any known enzyme-altering agent (e.g. CYP3A4 inducers or inhibitors), within 30 days of dosing. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to study drug administration.
• Any acute illness (e.g. acute infection) within 72 hours prior to study drug administration that is considered of significance by the Principal Investigator.
• Oral piercing of the tongue, inner lip or cheek.
• Presence of mouth ulcerations or any abnormalities of the oral cavity.
• Unwilling to abstain from smoking throughout the in-house stay at the CRC.
• Unwilling to abstain from alcohol use throughout the in-house stay at the CRC.
• Subjects who refuse to avoid strenuous physical activity throughout in-house stay in the CRC.
• Participation in another clinical trial with drugs received within 3 months prior to first dosing (calculated from the previous study's last dosing date).
• Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.
• Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).
• Inability to fast or consume the food provided in the study (including any known food allergies or food restrictions such as lactose intolerance or gluten-free diet).
• Subjects who are non-cooperative or unwilling to attend scheduled clinic visits and/or comply with the study protocol.