None listed
Conditions
Brief summary
For this study, Medlab Clinical proposes to conduct an open label, randomised comparison study to investigate the absorption and bioavailability characteristics of its NanoCelle™ nanotechnology cannabis formulation compared to a cannabis oil formulation at the same concentration, derived from the same raw cannabis oil material (same raw material batch) in order to progress its research into the NanoCelleTM delivery platform with respect to a cannabis extract.
Interventions
Sampling Method: Randomisation
Allocation: NanaBis™ (cannabis spray) group or cannabis oil group
Intervention Model: Comparison study
Masking: Open label
This is an open label, randomised comparison study. This study will be performed in healthy subjects to determine the absorption and bioavailability properties of a micellised (NanoCelle™) THC:CBD formulation in the form of an oro-buccal spray (NanaBis™) (treatment 1) when compared to an equal concentration cannabis oil formulation derived from
Sampling Method: Randomisation Allocation: NanaBis™ (cannabis spray) group or cannabis oil group Intervention Model: Comparison study Masking: Open label This is an open label, randomised comparison study. This study will be performed in healthy subjects to determine the absorption and bioavailability properties of a micellised (NanoCelle™) THC:CBD formulation in the form of an oro-buccal spray (NanaBis™) (treatment 1) when compared to an equal concentration cannabis oil formulation derived from the same raw cannabis oil material (treatment 2). NanaBis™ contains 7.5 mg THC and 7.5 mg CBD in 0.9 mL in 6 sprays. The cannabis oil formulation contains 7.5 mg THC and 7.5 mg CBD in 0.9 mL. Subjects will be screened from 28 days up to 2 days prior to study day 1 (dosing day). Enrolled participants will be admitted into the study facility on the evening of study day 0 and will be advised to fast from midnight. Randomisation to treatment 1 or treatment 2 will occur at this time. On study day 1 (morning), a pre-dose blood sample will be collected from the participants while fasting. Subsequently, 6 sprays of NanaBis™ (treatment 1) will be administered to the buccal mucosa of 5 volunteers and 0.9 mL drops of a cannabis oil formulation (treatment 2) will be administered sublingually to the remaining 5 volunteers at 0 minutes. Additional blood samples will be collected at the following time points: 30, 60, 90, 120, 180, 240, 360 minutes, 12 hours and at 24 hours. On study Day 2, after the 24 hours blood sample has been collected, participants will be discharged from the study facility. Participants will be closely monitored for adverse events while participating in the study. All blood samples will be processed at the study facility and plasma aliquots will be extracted from the whole blood samples and frozen at -80 degrees celsius. Plasma samples will be shipped to the analysing Laboratory in Thebarton SA (Agilex Biolabs).
Sponsors
Medlab Clinical
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1) Participants greater than or equal to 18 years of age at time of entry on the study; 2) Participants have the cognitive ability to understand the informed consent process and to give and sign informed consent to the experimental treatment; 3) Participants agree to undergo the insertion of an intravenous cannula on study day 1 for approximately 24 hours with multiple blood draws; 4) Participants agree to adhere to the study protocol; 5) Participants agree to abstain from using any other products containing cannabinoids for the duration of their participation in the study (from the signing of the informed consent to study completion on study day 7); 6) Participants are willing to take the study medication, which may exhibit psychoactive effects; 7) Participants consent to having urine tests for pregnancy if applicable; 8) Participants consent to having urine tests for recent illicit substance use including THC; 9) Participants have no history of any chronic diseases; 10) 10) Participants agree to not drive and/or operate heavy machinery from study day 0 to study day 7 (6 days after administration of the IP on study day 1).
Exclusion criteria
Key Exclusion Criteria: 1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs; 2) Current or previous allergies or allergic responses to herbal medicines of any kind; 3) Active substance abuse (alcohol or drug dependency); 4) Subjects who test positive to illicit substance use including THC during the screening visit assessments and on study day 0; 5) Pregnant or nursing an infant; 6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant; 7) Elevated liver enzymes 2x normal limits; 8) The current use of any dietary and herbal supplements (15 days wash-out period required); 9) The current use of any over-the-counter or prescription medications (15 days wash-out period required).
Outcome results
None listed