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CTRI Number  CTRI/2024/09/073580 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   An Single Dose Study Of Investigational Product Containing Coenzyme Q10 (CoQ10), in Healthy, Adult, Human Subjects Under Fasting Conditions. 
Scientific Title of Study   An Open-label, randomized, single dose, three-treatment, three-period, three-way crossover, oral bioavailability study of investigational product containing Coenzyme Q10 (CoQ10), in healthy, adult, human subjects under fasting conditions. 
Trial Acronym  CoQ10 
Secondary IDs if Any  
Secondary ID  Identifier 
VCR-CSP-24/008 version 1.0 Date 17July 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics, Ground floor, 38/1, Church Road, Marappa Garden,J C Nagar,Bengaluru

Bangalore
KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  gowdaambanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics, Ground floor, 38/1, Church Road, Marappa Garden,J C Nagar,Bengaluru


KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  gowdaambanna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shalini Dayananda 
Designation  Project Manager 
Affiliation  Vivatiq Clinical Research 
Address  358/274, Srigandha Nagar Main Road, Hegganahalli, Vishwaneedam Post, (near Peenya Industrial Area 2nd stage)

Bangalore
KARNATAKA
560079
India 
Phone  9980107723  
Fax  -  
Email  vivatiqcr@gmail.com  
 
Source of Monetary or Material Support  
Molecules BioLabs Pvt Ltd, Kinfra, Koratty, Kerala, India - 680309 
 
Primary Sponsor  
Name  Molecules BioLabs Pvt Ltd,  
Address  Kinfra, Koratty, Kerala, India - 680309 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Ambanna Gowda  Unitree Health Care Diagnostics   Ground floor , Consultation room, 38/1, Church Road, Marappa Garden, J C Nagar, Bengaluru 560006, Karnataka, India.
Bangalore
KARNATAKA 		 9845270377
-
gowdaambanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Antioxidant 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional CoQ10 (100 mg)  01 Cpsule to be taken once with water. 
Intervention  Liquid form of Liposomal CoQ10 formulation (100 mg)  01 sachet to be taken once with water. 
Intervention  Powder form of Liposomal CoQ10 formulation (100 mg)  01capsule to be taken once with water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2
2.Subject agrees avoid CoQ10 containing medications and dietary supplements from screening until last visit.
3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit.
4.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
5.Subjects generally healthy as documented at screening considered by the physician or principal/clinical investigator.
6.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.
7.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
8.Willing to consume ova-lacto vegetarian diet.
9.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
10.Generally healthy as documented by gynecological examination and breast examination (for female subjects during Period-I check-in only).
11.Female subjects of childbearing potential;
a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or
b.Surgically sterile (bilateral tubal ligation)
 
 
ExclusionCriteria 
Details  1.Evidence of allergy or known hypersensitivity to CoQ10 or other related drugs or other related drugs.
2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
3.Any major illness in the last three months or any significant ongoing chronic medical illness.
4.Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
5.History of alcohol addiction or abuse.
6.Malabsorption syndrome that affects CoQ10 metabolism.
7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100/min ventricular rate.
8.Gastrointestinal bleeding in past three months.
9.Uncontrolled diabetes mellitus.
10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
11.Psychopathic disorder, lack of cooperation.
12.Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
13.Taking more than 100 mg CoQ10 daily within 2 weeks to screening.
14.Consumption of caffeine and /or Xanthine containing products tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the oral bioavailability of investigational product (400 mg capsule containing NLT 100 mg of CoQ10/ Capsule for T1 and NLT 100 mg of CoQ10/ 10 mL Sachet for T2) of Molecules BioLabs Private Limited, and the reference product (400 mg capsules which contains NLT 100 mg of conventional CoQ10) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.  before and after dosing of study product. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of the subjects.  before and after dosing of study product. 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   08/09/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Coenzyme Q10 (CoQ10), also known as ubiquinone, is a fat-soluble, vitamin-like substance that resembles a vitamin E molecule. It is found in the inner membrane of mitochondria, where it participates in the electron transport chain- a series of reactions that generate adenosine triphosphate (ATP), the molecule that fuels cellular processes.Coenzyme Q10, often abbreviated as CoQ10, is a vital antioxidant and nutrient that plays a crucial role in generating energy in the cells. It is acts as an antioxidant, helping to neutralize free radicals and reduce oxidative stress in cells. Moreover, it plays a crucial role in maintaining cellular membrane integrity and in the production of energy in the form of ATP within cells, particularly in organs that require a lot of energy, such as the heart, liver, and kidneys.
CoQ10 is also available as a dietary supplement and is believed to have various health benefits, such as supporting heart health, promoting energy production, and acting as an antioxidant to protect cells from damage.
 
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