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CTRI Number  CTRI/2022/02/040335 [Registered on: 16/02/2022] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   An Open-Label, Balanced, Randomized, Single-Dose, Four-Treatment, Four- Period, Four- Sequence, Four-Way Crossover Study of Oral Bioavailability of Sundalp/Micellon, in Healthy, Adult, Human Subjects Under Fasting Conditions. 
Scientific Title of Study   AN OPEN LABEL BALANCED RANDOMIZED SINGLE DOSE FOUR TREATMENT FOUR PERIOD FOUR SEQUENCE FOUR WAY CROSSOVER STUDY OF ORAL BIOAVAILABILITY OF SUNDALP/MICELLON STANDARDIZED TO MIN. 2.25% CURCUMINOIDS CAPSULES 500 MG 1 SOFTGEL CAPSULE OF MANUFACTURED BY SFERALP SA VIACANTONALE 77 CH 6998 MONTEGGIO SWITZERLAND Tl SUNDALP MICELLON STANDARDIZED TO MIN. 2.25% CURCUMINOIDS CAPSULES 2000 MG 4*500 MG SOFTGEL CAPSULES OF MANUFACTURED BY SFERALP SA VIA CANTONALE 77 CH 6998 MONTEGGIO SWITZERLAND T2 WITH NOW CURCUMIN PHYTOSOME 500 MG TURMERIC RHIZOME EXTRACT CURCUMA LONGA PHOSPHATIDYL CHOLINE COMPLEX MERIVA TURMERIC PHYTOSOME STANDARDIZED TO MIN. 18% CURCUMINOIDS 90 MG 1 CAPSULE MANUFACTURED BY NOW FOODS 395 S.GLEN ELLYN RD BLOOMINGDALE IL 60108 USA Rl, JIGSAW HEALTH CURCUMIN C 3 COMPLEX 500 MG NLT 95% TOTAL CURCUMINOIDS CURCUMA LONGA RHIZOMES 1 CAPSULE MANUFACTURED BY JIGSAW HEALTH LLC 9035 E PIMA CENTER PKWY SUITE 4 SCOTTSDALE AZ 85258 USA R2 IN HEALTHY ADULT HUMAN SUBJECTS UNDER FASTING CONDITIONS  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SLS-CT-0001-21-CURC; Version 01; Date: 29 Apr 21.  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Senthurselvi MBBS MD 
Designation  Principal Investigator 
Affiliation  Spinos Life Science 
Address  No.29 A, Krishna Madhuravanam”, Vellakinar Pirivu, Thudiyalur, Coimbatore-641029. Tamil Nadu, India.

Coimbatore
TAMIL NADU
641029
India 
Phone    
Fax    
Email  senthurselvi.r@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd 
Address  2/5, Dahila Building, 3rd Floor 80 Feet Road, RMV 2nd Stage, Dollars Colony

Bangalore
KARNATAKA
560094
India 
Phone  09538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd 
Address  2/5, Dahila Building, 3rd Floor 80 Feet Road, RMV 2nd Stage, Dollars Colony

Bangalore
KARNATAKA
560094
India 
Phone  09538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Pharmabase SA, Schwerzistrasse 6, 8807 Freienbach, Switzerla 
 
Primary Sponsor  
Name  Pharmabase SA 
Address  Schwerzistrasse 6, 8807 Freienbach, Switzerland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Sferalp SA  Via Cantonnlc 77, CH-6998 Monteggio, Switzerland 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Senthurselvi  Spinos Life Science and Research Private Limited,  Spinos Life Science and Research Private Limited, No.29 A, “Krishna Madhuravanam”, Vellakinarpirivu, Thudiyalur, Coimbatore-641 029, Coimbatore TAMIL NADU
Coimbatore
TAMIL NADU 		 04222642491

senthurselvi.r@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Under Fasting Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jigsaw Health® Curcumin C 3 Complex® 500 Mg  In each period, after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of reference products R2(l Capsule) will be administered with 240 mL of water. 
Comparator Agent  Now® Curcumin Phytosome 500 Mg  In each period, after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of reference products Rl(l Capsule) will be administered with 240 mL of water. 
Intervention  Sundalp/Micellon capsules 2000 mg  In each period, after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of either test products T2 (4 Softgel Capsule) will be administered with 240 mL of water. 
Intervention  Sundalp/Micellon capsules 500 mg  In each period, after an overnight fasting of at least 10.00 hours, in the morning a single oral dose of test products T1 (1 Softgel Capsule) will be administered with 240 mL of water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Volunteers meeting all of the following criteria will be considered for enrollment in the study:
Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg per m2 to 29.99 kg per m2. Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check-in.
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal,
respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
Willing to consume Ova lacto vegetarian diet.
Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
Generally healthy as documented by gynecological examination and breast examination (for female subjects – period I only).
Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.
Female subjects of childbearing potential;
Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with the principal investigator; and/or
Surgically sterile (bilateral tubal ligation)
 
 
ExclusionCriteria 
Details  Volunteers with history or significant presence of the following will be excluded from
participation/enrollment in the study:

Evidence of allergy or known hypersensitivity to Curcuminor its inactive ingredients.
Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus and pre-existing gallbladder disease. Any major illness in the last three months or any significant ongoing chronic medical illness.
Renal or liver impairment.
Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
History of alcohol addiction or abuse.
Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea,
chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 48.00 hours prior to check-inand throughout the entire study.
Consumption of alcohol and its products, grapefruit and/ or its juice and poppy
containing foods within 72.00 hours prior to check-in and throughout the entire study.
Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products,
herbal medications within 07 days prior to check-in and throughout the study.
Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study.
Subject who had participated in any other study within the 90 days of check-in.
History of difficulty in swallowing.
History of difficulty in accessibility of veins.
Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of each period.
Positive results for alcohol test prior to check-in of each period.
Any blood donation / excess blood loss within 90 days of check-in.
Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
Use of hormone replacement therapy for a period of 06 months prior to dosing.
Female subjects demonstrating a positive pregnancy screen.
Female subjects who are currently lactating.
Females likely to become pregnant during conducting of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the oral Bioavailability of Sundalp/Micellon (Standardized to Min. 2.25% Curcuminoids) capsules 500 mg in healthy, adult, human subjects under fasting conditions.  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditions.  21 days 
 
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)   16/02/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Curcumin is a diarylheptanoid, belonging to the group of curcuminoids, which are natural
phenols responsible for turmeric’s yellow color. It is a tautomeric compound existing in enolic
form in organic solvents and as a keto form in water.
The most common applications are as a dietary supplement, in cosmetics, as a food coloring, and
as a flavoring for foods such as turmeric-flavored beverages. Curcumin incorporates several
functional groups whose structure was first identified in 1910. The aromatic ring systems, which
are phenols, are connected by two a, P-unsaturated carbonyl groups. The diketones form stable
ends and are readily deprotonated to form enolates; the alpha and beta-unsaturated carbonyl group is a good
Michael acceptor and undergoes nucleophilic addition.
Curcumin is used as an indicator for boron. It reacts with boric acid to form a red-color
compound, rosocyanine
 
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