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CTRI Number  CTRI/2021/02/031263 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 10/02/2021
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 Relative Bio availability Healthy, Adult, Human Subjects Under Fed Conditions. 
Scientific Title of Study   An Open Label Balanced Randomized Single Dose Four Treatment Four Period Four Sequence Four Way Crossover Study Of Relative Bioavailability Of T1 Curemin Actif Imm capsules 125 Mg Curcuminoids 125 Mg Turmeric Matrix Manufactured By Imm Institut Fuer Mitochondriale Medizin Pfalzburgerstrasse 43/44 10717 Berlin Germany T2 Meriva Thorne Curcumin Phytosome Curcuma Longa Extract Root Phospholipid Complex From Sunflower 500mg Curcumin & Other Curcuminoids 180 Mg Manufactured By Indena s p a Viale Ortles 12 20139 Milano Italy T3 Curcumin Loges capsules Novasol 50.4 Mg Curcuma Extract 35.5 Mg Curcumin Manufactured By DrLoges Co. Gmbh Post Box 1262 Schuetzenstrasse 5 21423 Winsen Luhe Germany T4 Curcumin Intravenous Infusion Burg Apotheke 150 Mg Curcumin Diferuloylmethan Manufactured By Burg Apotheke Koenigstein Frankfurterstrasse 7 16462 Koenigstein Im Taunus Germany In Healthy Adult Human Subjects Under Fed Conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRSenthurselvi 
Designation  Principal Investigator 
Affiliation  Spinos Life Science and Research Private Limited 
Address  Spinos Life Science and Research Private Limited, No.29 A, “Krishna Madhuravanam”, VellakinarPirivu, Thudiyalur, Coimbatore

Coimbatore
TAMIL NADU
641029.
India 
Phone  9750722032  
Fax    
Email  senthurselvi.r@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Divya Chandradhar  
Designation  CEO 
Affiliation  Bio Agile therapeutics Private Limited 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage

Bangalore
KARNATAKA
560094
India 
Phone  9538961761   
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya Chandradhar  
Designation  CEO 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761   
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Institut fuer mitochondriale Medizin Pfalzburgerstrasse 43/44 10717, Berlin Germany 
 
Primary Sponsor  
Name  Institut fuer mitochondriale Medizin 
Address  Pfalzburgerstrasse 43/44 10717, Berlin Germany 
Type of Sponsor  Research institution 
 
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 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 		 0422-2642491

senthurselvi.r@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Ashwin Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Under fed condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Meriva 500 SF  The subjects will be housed in the clinical facility from at least -60.00 hours pre-dose to 48.00 hours post-dose during each period. 
Comparator Agent  Curcumin Loges  The subjects will be housed in the clinical facility from at least -60.00 hours pre-dose to 48.00 hours post-dose during each period. 
Comparator Agent  IV Curcumin  The subjects will be housed in the clinical facility from at least -60.00 hours pre-dose to 48.00 hours post-dose during each period. 
Intervention  T1- CUREmin ACTIF   In each period, after overnight fasting of at least 10.00 hours. Standard breakfast will be served 30 minutes prior to dosing. The subjects will have to consume whole breakfast within 30 minutes of it being served a single oral dose of test product T (T1 or T2 or T3) will be administered with 240 mL of drinking water, (as per randomization schedule) at ambient temperature, to the subjects in sitting posture, under the supervision of Investigator or Medical Officer and trained study personnel including Quality Assurance auditor(s). This activity will be followed by mouth check with the help of torch light and tongue depressor to assess compliance to dosing. Study duration is 21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2(according to the formula of BMI weight (kg) / [height (m)]2).
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 standard breakfast.
Willing to comply to all requirements of this study protocol as well as instructed by thestudy 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 principal investigator; and/or Surgically sterile (bilateral tubal ligation) 
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Curcumin or 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 dosing and 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 dosing and throughout the entire study.
Subjects should not take any over the counter medicinal products, herbal medications within 07 days prior to study check-in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study.
An unusual or abnormal diet within 48.00 hours prior to dosing of each period, for whatever reason e.g. because of fasting due to religious reasons.
Systolic blood pressure less than 90mrn Hg or more than 140mmHg and diastolic blood pressure less than 60 mmHg or more than 90 mmHg.
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 this study period.
Positive results for alcohol breath 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 whose menstruation cycle coincides with the study periods
Female subjects who are currently lactating.
Females likely to become pregnant during conducting of the study.
Use of hormone replacement therapy for a Period of 06 months prior to dosing.
 
 
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 evaluate the Relative Bioavailability Of the test product in healthy, adult, human subjects under fed conditions  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fed conditions.   21 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   22/02/2021 
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  
The curcumin exhibits poor bioavailability is well documented. The major reasons attributed to the
low bioavailability of curcumin are poor absorption, rapid metabolism, and rapid systemic
elimination. In humans a comprehensive pharmacokinetic data do not exist.
The systemic elimination of curcumin is another contributing factor for low bioavailability of
curcumin.
Existing evidence in the
literature is insufficient to draw conclusions about the factors controlling the in vivo elimination halflife of curcumin, and future studies are warranted to address this issue.
 
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