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CTRI Number  CTRI/2025/07/090511 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Oral bioavailability study of nutraceutical Curcumin tablet in healthy human participants. 
Scientific Title of Study   A randomized, double-blind, single-dose, three-treatment, three-period, crossover oral bioavailability study comparing Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Tejo Swaroop Kumar 
Designation  Principal investigator 
Affiliation  Noah Therapeutics Private Limited 
Address  D.No.7-1-645/A,
Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India 
Phone  9958509329  
Fax    
Email  tejoswaroopd@noahtherapeutics.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D Tejo Swaroop Kumar 
Designation  Principal investigator 
Affiliation  Noah Therapeutics Private Limited 
Address  D.No.7-1-645/A,
Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India 
Phone  9958509329  
Fax    
Email  tejoswaroopd@noahtherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Dr D Tejo Swaroop Kumar 
Designation  Principal investigator 
Affiliation  Noah Therapeutics Private Limited 
Address  D.No.7-1-645/A,
Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India 
Phone  9958509329  
Fax    
Email  tejoswaroopd@noahtherapeutics.com  
 
Source of Monetary or Material Support  
Sabinsa Europe GmbH, Monzastraße 4A, 63225 Langen (Hessen), Germany Tel: 49 6103 2701111 
 
Primary Sponsor  
Name  Sabinsa Europe GmbH 
Address  Monzastraße 4A, 63225 Langen (Hessen), Germany Tel: 49 6103 2701111 
Type of Sponsor  Other [Research-oriented multinational health science company ] 
 
Details of Secondary Sponsor  
Name  Address 
SamiSabinsa Group Limited  Peenya Industrial Area Bangalore 560 058, Karnataka, India Tel: 80 6852 7777 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D Tejo Swaroop Kumar  Noah Therapeutics Private Limited  D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA 		 9958509329

tejoswaroopd@noahtherapeutics.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vasavi Medical and Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human (male and female) subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Tablet C3 Reduct® 140 mg  140 mg dose, single dose in one period, oral route of administration and single dose with 7 days washout period between each dose. Manufactured and distributed by: SAMI-SABINSA GROUP LIMITED (Formerly known as Sami Labs Limited) 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India Manufactured for: Sabinsa Europe GmbH, Monzastraße 4A, 63225 Langen (Hessen), Germany. 
Intervention  Tablet C3 Reduct® 400 mg  400 mg dose, single dose in one period, oral route of administration and single dose with 7 days washout period between each dose Manufactured and distributed by: SAMI-SABINSA GROUP LIMITED (Formerly known as Sami Labs Limited) 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India Manufactured for: Sabinsa Europe GmbH, Monzastraße 4A, 63225 Langen (Hessen), Germany 
Intervention  Tablet Curcumin C3 Complex® 500 mg  500 mg dose, single dose in one period, oral route of administration and single dose with 7 days washout period between each dose. Manufactured and distributed by: SAMI-SABINSA GROUP LIMITED (Formerly known as Sami Labs Limited),19/1 & 19/2, I Main, II Phase, Peenya Industrial Area Bangalore - 560 058, Karnataka, India Manufactured for: Sabinsa Europe GmbH, Monzastraße 4A, 63225 Langen (Hessen), Germany 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. All study participants must provide a voluntarily written and signed Informed Consent document to participate in the study.
2. Healthy, non-smoking, non-alcoholic, adult, human volunteer (Male and female (non-pregnant, non-lactating) aged 18 to 45 years.
3. Volunteer with a BMI between 18.5 kg/m2 and 29.9 kg/m2 (inclusive of both) and weight 50 kgs for male and 45 kgs for female volunteers.
4. Healthy according to the laboratory results and physical examination, performed at the time of screening.
5. Volunteer must have a normal renal function (Serum Creatinine up to 1.2mg/dL).
6. Volunteer must be willing to avoid foods containing curcumin and black pepper for at least 60 hours before dosing of each period.
7. Volunteers must have a normal 12-lead electrocardiogram (ECG).
8. Volunteers must have normal chest X- Ray (P/A view).
9. A negative urine screen result for drugs of abuse.
10. A negative alcohol breath or urine test result.
11. Volunteers able to communicate effectively.
12. A negative serum beta hCG test result for female volunteers.
13. Male participant agreeing to use appropriate contraceptive measures like double barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam) and should not donate sperm during the study and for 07 days following last dose of the study medication.
14. If the study participant is a female and is of child bearing potential, she must practice an acceptable method of birth control for the duration of the study and for 07 days following last dose of the study medication as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence:
Or
Is postmenopausal for at least 1 year.
Or
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteer). 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Curcumin or any of the excipients in the formulation.
2. History or presence of any medical condition or disease according to the opinion of the physician.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
4. Difficulty with donating blood or difficulty in accessibility of veins.
5. Difficulty in swallowing tablets.
6. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
7. An unusual or abnormal diet within 48.00 hours prior to study check-in, for whatever reason e.g., because of fasting due to religious reasons.
8. Use of St. Johns’ wort 3 weeks prior to study check-in and during the study.
9. Volunteers who had planned for any surgery during the course of the trial.
10. History or current diagnosis of any cancer.
11. History of gall bladder issues.
12. Volunteer with hyperacidity.
13. Volunteer with gastric/duodenal ulcers.
14. Volunteer with prior use of prescription H2 blockers, proton pump inhibitors, or blood sugar lowering agents.
15. Volunteer who are using CYP3A4 and CYP1A2 inhibitors (e.g., statins, antihypertensives, certain chemotherapeutics).
16. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
17. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
18. Pulse rate less than 60 beats/minute or more than 100 beats/minute.
19. Respiratory rate less than 14 breaths per minute or more than 18 breaths per minute.
20. Major illness in the past 90 days before screening.
21. Use of any prescribed medication or OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study and for 07 days following last dose of the study medication.
22. Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study.
23. Participation in any clinical study within past 90 days.
24. Donation of blood in the past 90 days prior to study check-in of Period-I.
25. In case of Female participants
• Pregnant or lactating Women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the oral bioavailability of Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions  The blood samples will be collected at 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours after drug administration in each period to evaluate the bioavailability. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety and tolerability of Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions.  Vital signs (body temperature, pulse rate, blood pressure and respiratory rate), assessment of health and well-being shall be recorded.
1.Before check-in of each period.
2.Before dosing in each period.
3.01.00, 03.00 and 07.00 hours after dosing in each period.
4.Before check-out of each period and/or withdrawal or at termination of the study. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 3 
Date of First Enrollment (India)   15/07/2025 
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="26" 
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 is a randomized, double-blind, single-dose, three-treatment, three-period, crossover oral bioavailability study comparing Tablet C3 Reduct® 140 mg, Tablet Curcumin C3 Complex® 500 mg and Tablet C3 Reduct® 400 mg in healthy adult human (male and female) subjects under fed conditions. The primary objective is to assess the oral bioavailability of investigational products. The secondary objective is safety and tolerability of investigational product. A total of 36 subjects will be enrolled in the study. The total duration of the study will be 26 days. 
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