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CTRI Number  CTRI/2024/01/061470 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 11/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Research on Quercetin Extracts: Studying Their Effects in Healthy People 
Scientific Title of Study   Clinical Pharmacokinetic Study of Quercetin Extracts in Healthy Human Volunteers. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC-CT-23-24-027 Version: 1.00; Dated, 28 November 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Principal Investigator  
Affiliation  Lokmanya Medical Research Centre 
Address  Lokmanya Medical Research Centre Fourth-floor OPD 401-314 B Telco Road Chinchwad Pune

Pune
MAHARASHTRA
411057
India 
Phone  9822057766  
Fax  -  
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  501-514, Crossroads, Wakad, Pune Pune MAHARASHTRA 411057 India

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  501-514, Crossroads, Wakad, Pune MAHARASHTRA 411057 India

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Source of Monetary or Material Support  
Tilman SA, Zoning industrial Sud 15 BE-5377 Baillonville, Belgium 
 
Primary Sponsor  
Name  Tilman SA 
Address  Zoning industrial Sud 15 BE-5377 Baillonville, Belgium 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Ninad Naik  Lokmanya Medical Research Centre and Hospital  4th-floor OPD 401 314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA 		 9637785567
-
naikninaad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Formulation A: Capsule Quercetin  Dose: 120 mg (Two soft capsules containing 60.0 mg of Quercetin per capsule), Frequency: Single dose- once only, Route of Administration: oral Duration: Single dose 
Intervention  Formulation B: Capsule Quercetin  Dose: 120 mg (Two hard capsules containing 60.0 mg of Quercetin per capsule), Frequency: Single dose- once only, Route of Administration: oral Duration: Single dose 
Intervention  Formulation C: Capsule Quercetin  Dose: 120 mg (One hard capsule containing 428.6 mg of rutin; equivalent of 120 mg of Quercetin), Frequency: Single dose- once only, Route of Administration: oral Duration: Single dose 
Intervention  Formulation D: Liposomal Quercetin  Dose: 4.8 ml (120 mg of quercetin) Frequency: Single dose - once only Route of Administration: Oral Duration: Single dose 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Healthy male and female human trial participants aged between 18 and 45 years (both inclusive); 2. Female trial participants must have a negative urine pregnancy test prior to the housing3. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4. Trial participants with a BMI between 18.50-28.00 kg per m2 and body mass, not less than 50.00 kg;5. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests);6. Trial participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording;7. Trial participants having a normal or clinically not significant chest X-ray (PA view);8. A negative alcohol breath test result;9. Trial participant able to communicate effectively and provide written informed consent; 10. Trial participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;11. Trial participants that can provide adequate evidence of their identity;12. Availability of volunteers for the entire study duration;13. Ability to fast for at least 14.00 hours and consume standard meals. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Quercetin or related product or any component of this intervention;
2. Incapable of understanding the informed consent information;
3. Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities;
4. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study;
5. History or presence of alcoholism or drug abuse;
6. History or presence of asthma, urticaria, or other allergic reactions;
7. History or presence of gastric and or duodenal ulceration;
8. History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion;
9. History or presence of cancer;
10. Difficulty with donating blood;
11. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study;
12. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
13. Smokers who smoke 9 or more cigarettes per day or inability to abstain during the study;
14. Trial participant consumed tobacco or tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study;
15. Trial participant consumed caffeine and or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit juice and poppy-containing foods for at least 48.00 hours before initiation of the study and throughout the study;
16. Major illness during the 90 days before screening;
17. Participation in a drug research study within 90 days of screening;
18. Donation of blood within 90 days of screening;
19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
20. History or presence of easy bruising or bleeding;
21. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
22. Females of childbearing potential with any one of the following reported and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year, or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii. Total hysterectomy and an absence of bleeding for at least 3 months;
23. Pregnant women and nursing mothers;
24. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;
25. Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.
26. Consumption of dietary supplements likely to provide polyphenols and Quercetine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Plasma pharmacokinetic parameters  Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 1h; 2h; 4h; 6h; 8h; 10h; and 24h. (Total 08 Time points). 
 
Secondary Outcome  
Outcome  TimePoints 
The tolerability and safety of the intervention will be assessed by evaluating:
1.Screening, pre-dose, and post-dose vital signs.
2.Clinical examination, ECG, chest X-ray, clinical laboratory testing (hematology, blood chemistry, liver function test (LFT), kidney function test (KFT), and other enzyme tests and urinalysis).
3.Adverse events, serious adverse events throughout the study.
4.Tolerability of the investigational product from administration to end of the study. 		 From Screening to end of the study 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 2 
Date of First Enrollment (India)   20/01/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Despite the development and utilization of quercetin formulations in clinical settings, challenges persist due to its low bioavailability and limited absorption. Current research predominantly focuses on the nonclinical stage, with limited clinical investigations. The absorption and metabolic mechanisms of quercetin in the human body remain unclear. To enhance its application in preventing and treating clinical diseases, there is a pressing need for in-depth pharmacokinetic studies to unravel the pharmacological mechanisms of quercetin.

Formulating an effective bioavailability strategy and undertaking a thorough pharmacokinetic investigation of Quercetin will be crucial for optimizing its therapeutic use by understanding its absorption, distribution, metabolism, and excretion. This study provides essential information on bioavailability, dosage determination, administration frequency, duration of action, tissue distribution, metabolism, and safety. Knowledge of metabolic pathways and elimination routes helps identify potential drug interactions, ensuring safe elimination without toxicity or accumulation.

Investigation of Quercetin’s pharmacokinetic profile will also contribute to understanding its safety and tolerability, including potential drug interactions and adverse effects. In pharmacokinetic investigations, selecting healthy human subjects is essential for accurate assessment of the active ingredient’s dynamics. It is imperative to include both males and females to detect potential gender-related variations in absorption, distribution, metabolism, and excretion processes. Hence, the goal of this study is to determine the pharmacokinetic profile, bioavailability of quercetin, a poor soluble compound, under formulations B, C and D compared to the formulation A in healthy human volunteers following acute oral administration under fasting conditions.

 

 
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