[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357658":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":26,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"One World Cannabis Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Orally Disintegrating MGC-ODT Tablet","EXPERIMENTAL","Administration of a single tablet of Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5mg THC and 5 mg CBD",[13],"Drug: OWCP Orally Disintegrating Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Sativex®","ACTIVE_COMPARATOR","Sativex® spray X 2 actuations (1 under the tongue and 1 inside the cheek administered within 2 min) - Reference Product \\[Each 100 μL spray contains 2.7 mg THC and 2.5 mg CBD, total per administration: 5.4 mg THC and 5.0 mg CBD\\]",[19],"Drug: Sativex",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","OWCP Orally Disintegrating Tablet","Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sativex","Sativex® Oromucosal Spray",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":26},"Tel Aviv Sourasky Medical Center","Tel Aviv","Israel (isr)","6423906","Israel","IL",{"type":40,"coordinates":41},"Point",[42,43],34.78057,32.08088,{"lat":43,"lon":42},{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100357658","phase-1-comparison-of-safety-tolerability-and-pharmacokinetics-of-medical-grade-cannabis-mgc-orally-disintegrating-tablets-with-buccal-sativex-in-healthy-adult-volunteers-100357658",false,"NCT03936907","Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers","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","Inclusion Criteria:\n\n* Subjects who provide written informed consent to participate in the study.\n* Subjects who agree to have their name and details disclosed to the Israeli Ministry of Health and other responsible official authorities, as per the local legal requirement for participation in a THC study.\n* Body Mass Index (BMI) ranging from 18 to \\\u003C30 kg\u002Fm2.\n* Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.\n* No history of either recurrent or current buccal disorders (e.g. aphthae, xerostomia, infections).\n* Supine blood pressure and heart rate within normal limits (systolic 90-140 mmHg; diastolic 50-90 mmHg, heart rate 45-100 beats per minute). No evidence of orthostatic hypotension.\n* No clinically significant abnormalities in clinical laboratory parameters (hematology, blood chemistry, or urinalysis).\n* Negative HIV 1\u002F2, HBSAg, HCV serology tests at Screening.\n* Subjects who agree to use an effective method of contraception during the course of the study. These include condom, having undergone a vasectomy or abstain from sexual intercourse.\n* No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse as determined on the Screening visit and on admission before dosing.\n* Willing to abstain from cannabis use 30 days before and throughout the study duration.\n* Subjects must agree not to engage in potentially hazardous activities such as operating machinery, working at heights (e.g. maintenance and construction, climbing a ladder) throughout the study duration.\n* Subjects must agree to abstain from driving from time of drug administration until 3 weeks after dosing.\n* Subjects must agree to eat all the food and beverages provided during the study, and only these meals.\n* Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* 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\u002For results of the study or contraindicates administration of the study medications.\n* History of fainting or recurrent dizziness.\n* History of epilepsy\u002Fseizures.\n* History of any significant psychiatric disorder i.e., mania, depression, or schizophrenia.\n* 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.\n* Known hypersensitivity to cannabinoids (including cannabis extracts), excipients of tablet or of Sativex.\n* Any history of cannabis dependence.\n* Any history of adverse events associated with cannabis intoxication.\n* 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.\n\nPositive urine drug of abuse test on Screening and on admission to the CRC before dosing.\n\n* A positive alcohol breath test on admission to the CRC before dosing.\n* History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis).\n* Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at the Screening visit.\n* Liver disease or liver injury manifested by clinically significant abnormal liver function tests\n* Subjects receiving concomitant antipsychotic, sedative, hypnotic or other psychoactive drugs.\n* 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.\n* Any acute illness (e.g. acute infection) within 72 hours prior to study drug administration that is considered of significance by the Principal Investigator.\n* Oral piercing of the tongue, inner lip or cheek.\n* Presence of mouth ulcerations or any abnormalities of the oral cavity.\n* Unwilling to abstain from smoking throughout the in-house stay at the CRC.\n* Unwilling to abstain from alcohol use throughout the in-house stay at the CRC.\n* Subjects who refuse to avoid strenuous physical activity throughout in-house stay in the CRC.\n* Participation in another clinical trial with drugs received within 3 months prior to first dosing (calculated from the previous study's last dosing date).\n* Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.\n* Subjects with an inability to communicate well with the investigators and CRC staff (i.e., language problem, poor mental development or impaired cerebral function).\n* 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).\n* Subjects who are non-cooperative or unwilling to attend scheduled clinic visits and\u002For comply with the study protocol.",true,"MALE","18 Years","45 Years",{"count":59,"type":60},16,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","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.",[66],"Healthy Subjects","COMPLETED","2019-07-23",{"date":70,"type":60},"2019-07-24",{"date":72,"type":60},"2019-04-15",{"date":74,"type":60},"2019-07-18",{"name":5,"class":6},1]