CTRI/2025/09/095460 [Registered on: 29/09/2025] Trial Registered Prospectively
Last Modified On:
29/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Non-randomized, Multiple Arm Trial
Public Title of Study
Study to Evaluate How the Body Absorbs 600mg Delayed-Release CBD Tablets in Healthy Adults Under Fasting and Fed Conditions.
Scientific Title of Study
An Open Label, Single-Center, Multi-Dose, Single-Treatment, Single-Sequence,
Single -Period, Oral Bioavailability Study of Test Product (T) Nano-Encapsulated Delayed-Release Cannabidiol Tablets 300 mg (Dose: 02 x 300mg = 600mg) manufactured by Dhee Lifesciences Pvt. Ltd., in Healthy, Adult, Human Subjects Under Fasting and Fed Conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
467-25, Version:00 dated: 06-Sep-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shailender Singh Tanwar MBBS
Designation
Principal Investigator
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8,S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra
Pune MAHARASHTRA 411057 India
Phone
9892023392
Fax
Email
drshailendersingh.bioradiuscro@gmail.com
Details of Contact Person Scientific Query
Name
Dr Senthil Thyagrajan
Designation
Head CRO
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8,S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra
Pune MAHARASHTRA 411057 India
Phone
9112126448
Fax
Email
head@bioradiuscro.com
Details of Contact Person Public Query
Name
Dr Senthil Thyagrajan
Designation
Head CRO
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8,S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra
IndiaLand Global Industrial Park, Plot No.8,S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra, India. Pune MAHARASHTRA
9112126448
head@bioradiuscro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Skinovate Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy human volunteer (18-45 years) with BMI 18.50–30.00 Kg/m2, free from significant medical conditions as confirmed as confirmed by clinical evaluation and laboratory tests.
Fasting Condition:
Subjects will be housed at BioRadius Therapeutics Research Private Limited Pune to maintain fasting for at least ten hours before Dose One.
Fed Condition:
Subjects will fast for at least ten hours before receiving a high fat high calorie non vegetarian meal approximately nine hundred fifty to one thousand kilocalories before Dose One. Medical attention will be provided for any adverse events.
Subjects will be discharged after the twelve hour blood sample on Day Four. Blood samples on Day Five Day Six and Day Seven will be collected on an ambulatory basis. This is a single period oral bioavailability study without a washout. Total study duration per subject will be at least eight days from check in to last sample.
Dosing Under Fasting Condition:
Morning Dose One on Day One:
After at least ten hours of fasting two tablets of the test product Nano Encapsulated Delayed Release Cannabidiol Tablets three hundred milligrams total six hundred milligrams will be given orally in sitting posture with two hundred forty plus or minus two milliliters of room temperature water.
Morning Doses on Day Two Day Three and Day Four:
After at least two hours of fasting two tablets of the test product six hundred milligrams will be given as above.
Evening Doses on Day One Day Two and Day Three:
Twelve hours after morning doses two tablets six hundred milligrams will be administered as above.
Dosing Under Fed Condition:
Morning Dose One on Day One:
After at least ten hours of fasting a high fat high calorie non vegetarian breakfast will be served thirty minutes before dosing. Subjects must consume the entire meal within thirty minutes. Two tablets six hundred milligrams will then be given in sitting posture with water.
Morning Doses on Day Two Day Three and Day Four:
After fasting for two hours the same breakfast will be served thirty minutes before dosing. Two tablets six hundred milligrams will be administered as above.
Evening Doses on Day One Day Two and Day Three:
After two hours fasting and the same breakfast thirty minutes before dosing two tablets six hundred milligrams will be administered twelve hours after the morning dose.
Dosing Instructions:
Two tablets of the test product manufactured by Dhee Lifesciences Private Limited will be administered orally in a sitting position. Subjects must swallow whole with approximately 240 ± 02 mL of room temperature water. .
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Healthy human volunteer of 18 to 45 years of age (both inclusive) and weight of at least 50 kg.
Capable and willing to give written informed consent and to adhere to the study requirements.
3Body Mass Index (BMI) between 18.50–30.00 Kg/m2.
4Healthy individuals as evaluated by personal history, medical history and general medical examination.
Absence of significant disease judged by investigator.
Volunteer with normal biochemical, haematological and urinary parameters or with abnormality considered to be clinically not significant and performed within 21 days prior to check in of Period I.
Have a normal 12 lead ECG or with an abnormality considered to be clinically not significant.
Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and VDRL
9. Negative urine scan for drugs of abuse like Cannabinoids-CANNAB/Tetrahydrocannabinol-THC, Amphetamine-AMP, Barbiturates-BAR, Cocaine-COC, Benzodiazepines-BZO and Morphine-MOR/Opioid-OPI.
Negative breath alcohol test.
Non-smoker.
Non-alcoholic.
Ability to fast for at least 10.00 hours before the Dose 01 (Morning dose) and will continue fasting for at least 02.00 hours post-dose.
Ability to fast for at least 10.00 hours before the high-fat high-calorie breakfast prior to Dose 01 (Morning dose) and will continue fasting for at least 02.00 hours post-dose.
Ability to fast for at least 02.00 hours before the Dose 02 (Evening dose), Dose 03 (Morning dose), Dose 04 (Evening dose), Dose 05 (Morning dose), Dose 06 (Evening dose) and Dose 07 (Morning dose) and will continue fasting for at least 02.00 hours post-dose.
Ability to consume standard meals and high-fat, high-calorie (approximately 950 to 1000 kcal), non-veg meal. .
Volunteer who can provide adequate evidence of their identity.
or 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.
ExclusionCriteria
Details
1. History of any medical disorder that is of significance in the investigator’s opinion.
2. History of any major surgical procedure in the past 3 months.
3. Present or past history of being on dialysis.
4. History or presence of significant haemopoetic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urinary retention, severe gastro-intestinal condition (including toxic mega colon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia or psychiatric disease or disorder.
5. History or presence of diabetes mellitus, tuberculosis and systemic hypertension.
6. History or presence of any medication for treatment of joint pain, inflammation, stone in kidney or urinary tract.
7. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to check in.
8. History of dysphasia.
9. History or presence of cancer.
10. Difficulty in donating blood.
11. Personal or family history of muscular disorders
12. Volunteer having any deformity that will affect venous access for cannulation.
13. History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake.
14. Consumption of caffeine and /or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) for at least 48.00 hours prior to check-in.
15. Consumption of tobacco containing products and grapefruit and its juice for at least 48.00 hours prior to check in.
16. Positive in breath test for alcohol consumption and urine scan for drug abuse during check-in.
17. History of any drug abuse.
18. History or presence of consumption of alcohol.
19. History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
20. Present or past history of intake of medications which potentially modify kinetics / dynamics of study medications or any other medication judged to be clinically significant by the investigator.
21. Participation in a drug research study within 90 days prior to check-in or donation of blood within 90 days prior to check-in.
22. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
23. Intake of OTC products, herbal medications, etc. within 7 days prior to check-in.
24. Intake of any prescription medications within 14 days prior to check-in that could affect the kinetics or dynamics of study medications in view of investigator.
25. An unusual diet for whatever reason (e.g. low sodium diet) for three weeks prior to check-in.
26. Had a depot injection or an implant of any drug 3 months prior to the commencement of this study.
27. Practicing Vegan Diet.
28. History of hypersensitivity to study medications cannabidiol or any excipient in Cannabidiol (Active Ingredient: cannabidiol Inactive Ingredients: dehydrated alcohol (7.9% w/v), sesame seed oil, strawberry flavor, and sucralose. Cannabidiol contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)).
For Female Volunteers
29. Female who is pregnant or lactating, or plans to become pregnant, or donate gametes during the study period or for 3 weeks after the subject’s last study-related visit (for eligible subjects only, if applicable) and unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study.
30. Female, demonstrating positive urine pregnancy test at the time of screening and serum pregnancy test before check-in and through the duration of the study
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To characterize the pharmacokinetic profile of nano-encapsulated delayed-release cannabidiol tablets Cannabidiol Tablets 300 mg (Dose: 02 x 300mg = 600mg) by determining
• Area under the concentration–time curve from time zero to the last measurable concentration
• Steady-state trough concentration
• Steady-state maximum plasma concentration
• Plasma levels of the primary active metabolite 7-hydroxy-cannabidiol
31 (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 Pre-morning Dose (within 05 minutes)
At Day 02 (within 05 minutes before Dose 03 and Dose 04)
At Day 03 (within 05 minutes before Dose 05 and Dose 06)
At Day 04 (within 05 minutes before Dose 07)
At Day 01:
Post-morning dose (Dose 01): 00.50, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, and 12.00 hours (12.00 hours Post dose 01 Samples shall be collected within 5 minutes before Dose 02)
Post-evening dose (Dose 02): 01.00, 02.00, 03.00, 04.00, 05.00 hours
At Day 04:
Post-morning dose (Dose 07): 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 24.00, 48.00, and 72.00 hours.
Samples from Day 01 to Day 04 up to the 12.00-hour post-dose time point will be collected in-house at the study facility.
amples collected after the Post dose 07 at 24.00, 48.00 and 72.00 hours, will be collected on an ambulatory basis. All the ambulatory samples will be collected within 04.00 hour of the scheduled sampling time point
Secondary Outcome
Outcome
TimePoints
Secondary Outcome:
To evaluate the safety and tolerability of nano-encapsulated delayed-release cannabidiol tablets, including:
Incidence and severity of adverse events (AEs)
Changes in vital signs (Blood Pressure, Radial Pulse Rate, and Body Temperature )
Laboratory test results (hematology, biochemistry)
31 (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 Pre-morning Dose (within 05 minutes)
At Day 02 (within 05 minutes before Dose 03 and Dose 04)
At Day 03 (within 05 minutes before Dose 05 and Dose 06)
At Day 04 (within 05 minutes before Dose 07)
At Day 01:
Post-morning dose (Dose 01): 00.50, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, and 12.00 hours (12.00 hours Post dose 01 Samples shall be collected within 5 minutes before Dose 02)
Post-evening dose (Dose 02): 01.00, 02.00, 03.00, 04.00, 05.00 hours
At Day 04:
Post-morning dose (Dose 07): 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 24.00, 48.00, and 72.00 hours.
Samples from Day 01 to Day 04 up to the 12.00-hour post-dose time point will be collected in-house at the study facility.
amples collected after the Post dose 07 at 24.00, 48.00 and 72.00 hours, will be collected on an ambulatory basis. All the ambulatory samples will be collected within 04.00 hour of the scheduled sampling time point
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
19/11/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="0" Days="8"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Open Label, Single-Center, Multi-Dose, Single-Treatment, Single-Sequence, Single -Period, Oral Bioavailability Study of Nano-Encapsulated Delayed-Release Cannabidiol Tablets 300 mg (Dose: 02 x 300mg = 600mg in Healthy adult human volunteers under fasting and fed conditions.
Eligible subjects will receive two tablets of the Test Product (Nano-Encapsulated Delayed-Release Cannabidiol Tablets 300 mg, total 600 mg per dose) twice daily for three consecutive days and a single morning dose on Day 4, administered orally with 240 milliliters of water by trained study personnel.
Fasting Condition:
Subjects will be housed at the clinical facility in Pune to maintain an overnight fast of at least 10 hours before Dose 01.
Day 01 Morning (Dose 01): Dose given after fasting.
Days 02, 03, and 04 Morning (Doses 3, 5, 7): Dose given after minimum 2-hour fasting.
Evening Doses on Days 01, 02, and 03 (Doses 2, 4, 6): Administered 12 hours after morning dose.
Fed Condition:
Subjects will fast overnight for 10 hours before receiving a high-fat, high-calorie non-veg meal (950–1000 kcal).
Day 01 Morning (Dose 01): Meal given 30 minutes prior to dosing.
Days 02, 03, and 04 Morning (Doses 3, 5, 7): Same meal served 30 minutes before dose, after 2-hour fast.
Evening Doses on Days 01, 02, and 03 (Doses 2, 4, 6): Same meal protocol, followed by dosing 12 hours after morning dose.
Dosing Instructions:
All doses are administered orally in sitting position, with 240 milliliters of water at ambient temperature. Tablets must be swallowed whole and not crushed or chewed.
Pharmacokinetic (PK) Analysis:
Primary PK Parameters:
AUC0-t
Ct ss
Cmax ss
Secondary PK Parameters:
Tmax ss
Half-life
Elimination rate constant
Cmin ss
Cavg ss
Fluctuation percent and Swing percent
PK analysis will be performed using Phoenix WinNonlin version 8.3.3 or higher or SAS version 9.4 or higher.
Statistical Analysis:
Log-transformed values of AUC, Cmax ss, and Ct ss will be analyzed using ANOVA.
Intra-subject variability, power, geometric mean ratios, and 90 percent confidence intervals will be calculated to assess the bioavailability of the test product under fasting conditions.