Pain Clinical Trial
Official title:
Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations
The oral bio-availability of cannabidiol (CBD) is low due to poor water solubility and susceptibility to extensive first pass metabolism, resulting in relative bio-availability of 6%.This project is designed to evaluate the plasma concentration vs. time profile of a self emulsifying drug delivery system termed Long Chain Nano Lipospheres (LNL) for enhancing the oral bio-availability of cannabidiol (CBD). The main goal of this study is to evaluate the bio-equivalence of CBD in the LNL product, compared to CBD in a sesame oil vehicle and CBD without any formulation, in powder form. Bio-equivalence is measured by AUC 0-24h, Tmax and Cmax.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | February 19, 2025 |
Est. primary completion date | February 19, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Men 18 through 45 years of age with body mass index in the range of: 19 through 30 kg/m2. 2. Participants should be able to ingest and absorb oral medications. 3. Subjects must be in good health as determined by medical history, vital signs measurements, physical examination (routine examination performed by the general physician), and clinical laboratory tests (blood count and biochemistry conducted in the Health maintenance organization in Israel( "kupat holim"). 4. Potential participants will undergo a screening/explanatory interview in which their compatibility will be examined. The screening interview will be held prior to the first day of trial (at least during the near month preceding the first day of trial). 5. Subjects must be able to understand and comply with the requirements of the study (e.g. all medication, dietary, and alcohol restrictions). 6. Subjects must provide written informed consent to participate in the study after reading the information and consent form, and after having an opportunity to discuss the study with the investigator. 7. Subjects must complete the screening process within 4 weeks prior to the admission visit. Exclusion Criteria: 1. Previous participation in an research trial involving administration of any of the investigated compounds within one month prior to the current study. 2. The subject is suffering from, or has a clinically significant history of, one or more of the following: impaired glucose tolerance, diabetes mellitus, renal disease, edema, stroke or neurological disorder, rheumatological disorder (including arthritis, joint or tendon abnormalities), pulmonary disorder (including a personal history of asthma, but excluding resolved pediatric asthma), hepatic disorder, has a personal history of seizures, history of psychosis any addictive or other psychiatric disease disorder or a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject by participation in the study. 3. The subject has a known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 1 or 2. 4. Any history of adverse events associated with cannabis intoxication or dependence. 5. A subject that has used one of the forbidden drugs, substances or foods as follows: - Any investigational product (THC or/and CBD ingestion or smoking) within one month preceding the study. - Any prescription or non-prescription medication (including herbal remedies, vitamins or dietary supplements) or vaccine within 14 days of the first day of study drug administration (Day 1) or within 5 half-lives before the first day of study drug administration, whichever is longer. Exceptions are locally acting medications (eg, topical creams), which are not allowed within 5 days of study drug administration, and the occasional use of acetaminophen (up to 3 g/day) and ibuprofen (up to 1200 mg/day). - Consumption of grapefruit, grapefruit juice, Seville oranges, pomelo containing products, within the 14 days prior to Day -1 and then throughout the entire study. - Consumption of excessive amounts of alcoholic beverages, defined as >3 drinks per day (beer, wine, or distilled spirits), or unwilling to comply with the restricted use of alcohol during the study (48 hours prior to admission and throughout the study), who have history of alcoholism. 6. Subject that has any condition that may possibly interfere with drug absorption, distribution, metabolism, or excretion (eg, previous surgery on the gastrointestinal tract [including removal of parts of stomach, bowel, liver, gall bladder, or pancreas] or stomach banding). 7. Exhausting physical exercise 48 hours prior to drug administration. 8. The subject does not agree to abstain from excessive caffeine and xanthine containing foods and beverages (ie, equivalent to >4 cups brewed coffee per day) from 48hr prior to Day -1 and throughout the entire study. 9. Those who had donated >0.5 L blood within 30 days of study. 10. Abnormal blood pressure and heart rate values according to the following criteria: - The subject has a supine pulse rate outside of the range of 40 to 100 bpm (following at least a 10-minute rest) measured at screening or Day -1. - The subject has a supine blood pressure outside of the range of 90 to 139 mm Hg systolic or 50 to 89 mm Hg diastolic (following at least a 10 minute rest) measured at screening or Day-1. Note: The blood pressure measurement may be repeated up to 3 times to meet eligibility requirements. In this case, the average of these 3 measurements must meet eligibility criteria. 11. A subject with a clinically significant history of drug allergies (including cannabis extracts, ethanol, or sesame oil), drug hypersensitivity or history of idiosyncratic reactions to any drug. 12. History of abuse of any drug/chemical. 13. Inability to relate to and/or cooperate with the investigators. 14. A subject with any other condition, which, in the opinion of the investigator, makes the subject inappropriate for the study. |
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters of CBD | Assesment of the pharmacokinetic profile of Cannabidiol in healthy volunteers. Plasma concentrations will be determined using HPLC-MS/MS validiated assay. The unit of measure will be provided as ng/ml. | 24 Hours | |
Secondary | Exposure to the metabolites of the study drugs | Assessment of the metabolic profile of the major cannabidiol metabolites: 7-hydroxy-CBD and CBD-glucoronide-11 in healthy volunteers. Plasma metabolites concentrations will be determined using HPLC-MS/MS validiated assay. The unit of measure will be provided as ng/ml. | 24 hours | |
Secondary | Measurement of pharmacodynamic (PD) variables following CBD administration | Cold pressor test - volunteers are requested to immerse their hands in ice cold water for up to two minutes. During the assesment the participants are requested to rate their pain scores from 0-100, at 15 second intervals for the duration of the two minute test time. In the event that the participant should remove their hands at any point during the assessment the VAS score is rated 100. This assesment is repeated muliple times for each participant throughout each study cycle. |
24 hours | |
Secondary | Measurment of reaction time and coordination following CBD administration. | Aim trainer test- A computerized eye hand coordination test to assess the response time and coherence following CBD administration. This test will be repeated multiple throughout each CBD administration cycle. | 24 hours |
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