None listed
Conditions
Interventions
Intervention1: Encapsulated Nano-Cannabidiol-600mg, uncoated tablets: Each subject will be administered a single tablet of the test product Encapsulated Nano- Cannabidiol 600 mg (uncoated tablets) m
Sponsors
Dhee Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: For Both Male and Female Volunteers Healthy volunteer age 18 to 45 years weight equal to or greater than 50 kg Willing and able to give written informed consent BMI between 18.50 and 30.00 kg per meter squared Healthy as per personal and medical history and general examination No significant disease as judged by the investigator Normal or clinically insignificant laboratory parameters within 21 days before Period I Normal or clinically insignificant 12 lead ECG Negative for HIV Hepatitis B and Hepatitis C and VDRL Negative urine drug screen for THC AMP BAR COC BZO MOR or OPI Negative breath alcohol test Non smoker Non alcoholic Able to fast 10 hours before and 2 hours after morning dose Able to fast 4 hours before and 2 hours after evening dose Able to consume standard meals Able to provide valid identity proof For Female Volunteers Only Female of childbearing potential must have a negative urine pregnancy test performed within 21 days prior to initiation of the study and must have a negative serum beta human chorionic gonadotropin beta HCG pregnancy test prior to check-in of each period Female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study-related visit for eligible subjects only if applicable has a negative pregnancy test and is of non-childbearing potential defined as At least 1 year post-menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy Or Of childbearing potential and willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study Double barrier methods such as condoms cervical cap diaphragm and vaginal contraceptive film with spermicide Intrauterine device IUD with a low failure rate less than 1 percent per year Or Of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
Exclusion criteria
Exclusion criteria: For Both Male and Female Volunteers: 1.Any significant medical disorder (as per investigator s opinion). 2.Major surgery in the past 3 months. 3.History of dialysis. 4.Significant history/presence of disorders (haemopoetic, cardiac, liver, kidney, GI, endocrine, neuro, psych, etc.). 5.History/presence of diabetes, TB, or systemic hypertension. 6.Medications for joint pain, inflammation, kidney/urinary stones. 7.Dehydration due to vomiting/diarrhoea within 24 hrs before check-in. 8.History of dysphasia. 9.History or presence of cancer. 10.Difficulty in blood donation. 11.Personal/family history of muscular disorders. 12.Deformity affecting venous access. 13.Significant medical disorder (duplicate of point 1). 14.Unable to abstain from caffeine/xanthine-containing products. 15.Intake of caffeine/xanthine products within 24 hrs of check-in. 16.Use of tobacco or grapefruit (and juice) within 48 hrs of check-in. 17.Positive breath alcohol or urine drug screen at check-in. 18.History of drug abuse. 19.History of alcohol consumption. 20.Food/vegetable allergies or hypersensitivity reactions. 21.Use of medications that could affect study drug kinetics/dynamics. 22.Participation in drug research or blood donation within last 90 days. 23.Positive for HIV, Hepatitis B/C, or VDRL. 24.Use of OTC/herbal meds within 7 days before check-in. 25.Use of prescription meds affecting study drug within 14 days. 26.Unusual diet (e.g., low sodium) within 3 weeks before check-in. 27.Drug depot injection/implant in past 3 months. 28.Practicing a vegan diet. 29.Known hypersensitivity to cannabidiol or any EPIDIOLEX excipients. For Female Volunteers Only: 30. Pregnant, lactating, planning pregnancy/gamete donation, or unwilling to use contraception during study and 3 weeks after. 31. Positive urine/serum pregnancy test during screening or before each period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters Cmax, Tmax, AUC of both products, specifically focusing on the area under the concentration-time curve AUC from time zero to the last measurable concentration AUC0-t and the area under the curve extrapolated to infinity AUC0-inf including the measurement of the 7OH metabolite levelsTimepoint: In each period 19 1 x 05 mL blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected as per following schedule. Pre-dose sample will be collected at At Day 01 within 5 minutes before Dose 1 and Dose 2 At Day 02 within 5 minutes before Dose 3 and Dose 4 At Day 03 within 5 minutes before Dose 5 and Dose 6 Post-dose samples will be collected after administration of Dose 6 at At Day 03 00.25, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00 hours post dose 6 At Day 04 06.00, 08.00, 12.00, 24.00 hours post dose 6 At Day 05 48.00 hours post dose 6 At Day 06 72.00 hours post dose 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessments, including: Incidence and severity of adverse events (AEs) Changes in vital signs (blood pressure, heart rate, temperature) Laboratory test results (hematology, biochemistry) Subjective assessments of tolerability (using a visual analog scale for discomfort or side effects) Timepoint: Vital signs (including blood pressure, pulse rate, and body temperature) will be recorded at specific intervals throughout the study. For Dose 01 to Dose 05, vital signs will be measured at 01.00 and 03.00 hours post-dose. Following administration of Dose 06, vital signs will be recorded on Day 03 and Day 04 at 01.00, 03.00, and 06.00 hours post-dose, within a 40-minute window from the scheduled time in each period. Additionally, vital signs will also be assessed during each ambulatory sample collection, specifically on Day 04 (24.00 hours post-dose 6), Day 05 (48.00 hours post-dose 6), and Day 06 (72.00 hours post-dose 6). | — |
Countries
India
Contacts
Public ContactDr Senthil Thyagrajan
BioRadius Therapeutic Research Pvt. Ltd.
Outcome results
None listed