CTRI/2025/04/084854 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On:
15/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Randomized, Crossover Trial
Public Title of Study
A study comparing how well the body absorbs two different formulations of Curcuma longa (Turmeric) extract in healthy adults under (fasting conditions).
Scientific Title of Study
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Relative Bioavailability Study Comparing Test Product (T) C. longa Extract Formulation 60 percent (200 mg) with Reference Product (R) C. longa Extract 95 percent (1000 mg) in Healthy, Adult, Human Subjects Under Fasting Condition
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
434-24 Version: 00 Date: 11-Feb-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shailender Singh Tanwar
Designation
M.B.B.S.
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra, India.
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, India.
Pune MAHARASHTRA 411057 India
Phone
9112126448
Fax
Email
head@bioradiuscro.com
Details of Contact Person Public Query
Name
Mr Ajjarapu Srinivasu
Designation
Manager
Affiliation
Chemiloids Life Sciences Private Limited.
Address
40-15-14, Brindavan Colony, Labbipet,
Vijayawada, Andhra Pradesh, India
Krishna ANDHRA PRADESH 520010 India
Phone
8662464446
Fax
Email
srinivasu@chemiloids.com
Source of Monetary or Material Support
Chemiloids Life Sciences Private Limited., 40-15-14, Brindavan Colony, Labbipet, Vijayawada - 520010, Andhra Pradesh, India
Primary Sponsor
Name
Chemiloids Life Sciences Private Limited.
Address
40-15-14, Brindavan Colony, Labbipet, Vijayawada - 520010, Andhra Pradesh, India
Type of Sponsor
Other [Chemiloids Life Sciences Private Limited CLSPL]
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shailender Singh Tanwar
BioRadius Therapeutic Research Pvt. Ltd.
BioRadius Therapeutic Research Pvt. Ltd.,
IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245,
Hinjawadi Phase I, Pune- 411057, Maharashtra, India. Pune MAHARASHTRA
09892023392
drshailendersingh.bioradiuscro@gmail.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 of 18 to 45 years of age (both inclusive) and weight of at least 50 kg. The study will be conducted under fasting condition.
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Curcuminoids longa extract 95% (1000mg) Manufactured by Chemiloids Life Sciences Private Limited, India
After overnight fasting of at least 10.00 hours, single dose of Reference Product (R) will be administered orally to the subjects in sitting posture with about 240 ± 02 mL of water, at ambient temperature in the morning, as per the randomization schedule. Administration of IPs will be done by trained personnel in the presence of PI / CI / Designee and QA personnel. Subjects will be instructed not to chew or crush the investigational product but to consume it as a whole. To ensure that the subject has swallowed the IP, subject’s oral cavity (mouth) will be checked by trained study personnel using torch and tongue depressor. Washout and Total Duration: This is a two-period study with at least 07 days washout period between each successive dosing day. Total expected duration of the study for the subject will be of at least 10 days from the day of check-in of Period-I to the last sample collection of period II.
Intervention
Curcuminoids longa extract Formulation 60% (200 mg) manufactured by Chemiloids Life Sciences Private Limited, India
After overnight fasting of at least 10.00 hours, single dose of Test Product (T) will be administered orally to the subjects in sitting posture with about 240 ± 02 mL of water, at ambient temperature in the morning, as per the randomization schedule.
Administration of IPs will be done by trained personnel in the presence of PI / CI / Designee and QA personnel. Subjects will be instructed not to chew or crush the investigational product but to consume it as a whole.
To ensure that the subject has swallowed the IP, subject’s oral cavity (mouth) will be checked by trained study personnel using torch and tongue depressor.
Washout and Total Duration: This is a two-period study with at least 07 days washout period between each successive dosing day. Total expected duration of the study for the subject will be of at least 10 days from the day of check-in of Period-I to the last sample collection of period II.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1.Healthy human volunteers aged 18-45 years and weighing at least 50 kg.
2.Capable and willing to give informed written consent and adhere to study requirements.
3.BMI between 18.50–30.00 kg/m².
4.Healthy individuals based on personal history, medical history, and general medical examination.
5.No significant disease as judged by the investigator.
6.Normal biochemical, hematological, and urinary parameters, or clinically insignificant abnormalities (within 21 days prior to Period I check-in).
7.Normal 12-lead ECG or clinically insignificant abnormalities.
8.Negative for HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody, and VDRL.
9.Negative urine screening for drugs of abuse (Cannabinoids, Amphetamine, Barbiturates, Cocaine, Benzodiazepines, Morphine).
10.Negative breath alcohol test.
11.Non-smoker.
12.Non-alcoholic.
13.Ability to fast for at least 10 hours prior to dosing and 4 hours after dosing.
14.Ability to consume standard meals.
15.Ability to consume turmeric-free and black pepper-free food.
16.Willingness to adhere to protocol requirements and provide written informed consent.
17.Can provide adequate evidence of identity.
For Female Volunteers:
12. Negative pregnancy tests
13. Not pregnant, lactating, or attempting pregnancy
14. Use of contraception if sexually active and of childbearing potential
ExclusionCriteria
Details
1.History of any significant medical disorder as determined by the investigator.
2.History of any major surgical procedure within the past 3 months.
3.History of being on dialysis.
4.History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urinary retention, severe gastrointestinal condition, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, or psychiatric disorder.
5.History or presence of diabetes mellitus, tuberculosis, or systemic hypertension.
6.History or current use of medication for joint pain, inflammation, kidney stones, or urinary tract issues.
7.Recent history of dehydration due to diarrhea, vomiting, or any other cause within 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.Any deformity affecting venous access for cannulation.
13.History or presence of significant medical disorders as determined by the investigator.
14.History of alcohol consumption.
15.Habituation to coffee, tea, or other xanthine-containing products and inability to withhold intake.
16.Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in.
17.Consumption of tobacco-containing products, grapefruit, and its juice within 48 hours prior to check-in.
18.Positive breath test for alcohol or urine scan for drug abuse during check-in.
19.History of drug abuse.
20.History of allergy to vegetables, food substances, or any other hypersensitivity reactions.
21.Current or past use of medications that may modify the kinetics/dynamics of study medications or other medications deemed clinically significant by the investigator.
22.Participation in a drug research study or blood donation within 90 days prior to check-in.
23.Positive screening test result for HIV, Hepatitis B, Hepatitis C, or VDRL.
24.Intake of OTC products, herbal medications, or similar within 7 days prior to check-in.
25.Intake of prescription medications within 14 days prior to check-in that may affect the study medications.
26.Unusual diet (e.g., low sodium) within 3 weeks prior to check-in.
27.Depot injection or drug implant within 3 months prior to study commencement.
28.Following a vegan diet.
29.History of hypersensitivity to study medications, related medications, or excipients in the formulation.
30.Consumption of food containing curcumin or black pepper within 48 hours prior to dosing.
31.History or evidence of hypersensitivity to curcumin, Piperine, or their metabolites.
32.Any blood donation or excessive blood loss within 90 days of check-in.
For Female Volunteers: 33. Pregnant or lactating females, those planning to become pregnant, donate gametes during the study, or unwilling to use appropriate contraceptive methods during the study and for 3 weeks after the last study-related visit. 34. Female volunteers with a positive urine pregnancy test at screening, and a positive serum pregnancy test before check-in for each period and during the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess the comparative pharmacokinetic profile and bioavailability of a single oral dose of the
Test Product (T) Curcuminoids Formulation 60% (200 mg) Manufactured by Chemiloids Life Sciences Private Limited, India with Reference Product (R) Curcuminoids unformulated 95% (1000mg) anufactured by Chemiloids Life Sciences Private Limited, India in Healthy, Adult,
Human Subjects under Fasting Conditions
In each period, total of 11 (1 x 06 mL) blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected at 00.00 (pre-dose) within 02.00 hours prior to dosing and the post dose blood samples will be collected 00.50, 01.00, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose in each period.
Secondary Outcome
Outcome
TimePoints
To monitor the safety and tolerability of a single oral dose administered in Healthy, Adult, Human Subjects Under Fasting Condition.
Medical examination:
During screening, Before check-in of each period, Before check-out of each period and / or at termination of study.
Vitals (Blood Pressure, Radial Pulse, Respiratory Rate and Body
Temperature) and Well-being recording:
During screening, Before check-in of each period, Before drug administration (within 02.00 hours prior to dosing) of each
period. Prior to checkout of each period.
At 01.00, 02.00, 06.00 and 12.00 hours (within ±40 minutes of the
scheduled time) post dose in each period.
Target Sample Size
Total Sample Size="16" Sample Size from India="16" 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)
26/04/2025
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="10"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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 open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover bioavailability study aims to assess the comparative pharmacokinetic profile and bioavailability of two Curcuma longa extract formulations in healthy adult human subjects under fasting conditions. The study will compare a 60% curcuminoids formulation (200 mg) as the test product (T) with a 95% curcuminoids formulation (1000 mg) as the reference product (R), both manufactured by Chemiloids Life Sciences Pvt. Ltd., India. The primary objective is to evaluate the pharmacokinetic parameters, including Cmax and AUC0-t, while the secondary objective is to monitor the safety and tolerability of the formulations. The study will enroll 16 healthy subjects, with two additional subjects as reserves in case of dropout. The subjects will be randomly assigned to receive either the test or reference product in each of two periods, with a washout period of at least 7 days between doses. Randomization will be performed using a computer-generated sequence. The pharmacokinetic parameters will be analyzed using Non-Compartmental Analysis (NCA) with Phoenix WinNonlin Software or SAS® System, and the bioequivalence of the test product to the reference will be assessed through statistical analysis, including a two-way analysis of variance (ANOVA) model and geometric mean ratios (GMRs) for Cmax and AUC0-t. If the 90% confidence interval for GMR falls within 80-125%, the test product will be considered bioequivalent. Safety will be monitored through vital sign assessments, medical examinations, and laboratory tests, with adverse events (AEs) being recorded and managed appropriately. The study will be conducted in accordance with ICH GCP, ICMR guidelines, CDSCO regulations, and other applicable local standards, and ethical approval will be obtained before the study begins.