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CTRI Number  CTRI/2025/10/096150 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study to find out how well Coenzyme Q10 (100 mg) capsules are absorbed in the body when taken on an empty stomach. 
Scientific Title of Study   An Open-Label, Balanced, Randomized, Single-Dose, Three Treatment, Three-Sequence, Three-Period, Three-Way Crossover, Truncated, Oral Relative Bioavailability Study Comapring NOVASOL® Q 100 MG Capsules Manufactured By Aquanova AG & KANEKA UBIQUINOL® Manufactured by Sunday Natural Versus NATIVE COENZYME Q10 100 MG Capsules Manufactured by Inner Mongolia Kingdomway Pharmaceutical Limited in Healthy, Adult Human Subjects Under Fasting Conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BSP-25-074/SLS-CT-0010-25-COEN   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Velavan Kandappan 
Designation  Principal Investigator  
Affiliation  Erode Cancer center 
Address  1/393, Velavan Nagar, Perundurai Road, Thindal, Erode.

Erode
TAMIL NADU
638012
India 
Phone  9842334222  
Fax    
Email  Kvels@rediffmail.com   
 
Details of Contact Person
Scientific Query  
Name  Divya C 
Designation  CEO 
Affiliation  BioAgile Therapeutics Private Limited 
Address  2/5 dahlia building, 3rd floor, RMV 2nd stage, 80 feet road, bangalore 560094, Karnataka, India

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 Private Limited 
Address  2/5 dahlia building, 3rd floor, RMV 2nd stage, 80 feet road, bangalore 560094, Karnataka, India

Bangalore
KARNATAKA
560094
India 
Phone  09538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Aquanova AG Birkenweg 8-10 64295 Darmstadt/Germany 
 
Primary Sponsor  
Name  Aquanova AG  
Address  Brikenweg 8-10 I 64295 Darmstadt I Germany. 
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 Velavan Kandappan  Erode Cancer Center   1/393, Velavan Nagar, Perundurai Road, Thindal, Erode-638012, Tamilnadu, India.Department : Clinical Research Department  Ground Floor, Room No: 33
Erode
TAMIL NADU 		 9842334222

Kvels@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Erode cancer center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Under Fasting Conditions  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kaneka Ubiquinol® 100 mg Capsules  Subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 14 days will be maintained between each dosing period. 
Comparator Agent  Native Coenzyme Q10 100 mg Capsules   Subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 14 days will be maintained between each dosing period. 
Intervention  NovaSOL® Q 100 mg Capsules  Subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 72.00 hours post-dose. A washout period of at least 14 days will be maintained between each dosing period.  
 
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 and Body
Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2 (according to the
formula 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 are
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 not limited to an evaluation of the cardiovascular, gastrointestinal,
respiratory, musculoskeletal, and central nervous system) and vital sign
assessments.
Generally healthy, as documented by a 12-lead electrocardiogram (ECG), Chest
X-Ray and clinical laboratory assessments.
Willing to consume Ovo lacto-vegetarian diet.
Willing to comply with all requirements of this study protocol as well as
instructions from the study personnel.
Non- smokers.
Generally healthy, as documented by gynaecological examination and breast
examination for female subjects – period I only.
Females of childbearing potential must have a negative serum pregnancy test
performed within 21 days prior to the initiation of the study and a negative urine
pregnancy test prior to check-in for each period.
If the subject is female currently not pregnant not lactating, or not attempting to
become pregnant for 4 weeks before the screening visit throughout the duration
of the study, and 3 weeks after the subjects last study related visit (for eligible
subjects only if applicable) has a negative serum pregnancy test and is of non childbearing potential defined as more than one year post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause)
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy)
or is of
childbearing potential willing to commit to using a consistent and acceptable
method of birth control as defined below for the duration of the study
double barrier methods (condoms, cervical cap, diaphragm, and vaginal
contraceptive film with spermicide)
intrauterine device (IUD) with a low failure rate of less than one percent per year
or is of
childbearing potential and not sexually active, willing to commit to using a
consistent and acceptable method of birth control as defined above for the
duration of the study, in the event the subject becomes sexually active.


 
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Coenzyme Q10 or its inactive
ingredients.
Subjects with hepatic encephalopathy, cholestasis, myasthenia preexisting 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 that might compromise the haemopoeitic,
gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory,
central nervous system, or any other body system, including presence of Diabetes
Mellitus and Psychosis.
History of alcohol addiction or abuse.
Consumption of caffeine and or xanthine containing products (i.e., coffee, tea,
chocolate, caffeine-containing sodas, colas, etc.), cigarettes, and tobacco
containing products for at least 48.00 hours prior to check-in and throughout the
entire study.
Consumption of alcohol and its products, and poppy containing foods within 48.00
hours prior to clinic admission and throughout the entire study.
Grapefruits and its products should not be taken for 14 days prior to trial.
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 study check-in and
throughout the study.
Subjects who have taken any unusual diet, for whatever reason (e.g. low salt) for
48.00 hours prior to dosing 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.
Absisitence from OTC drugs for past 06 months.
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 or excess blood loss within 90 days of check in.
Ingestion of any hormonal agent at any time within 14 days prior to the start of the
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 are likely to become pregnant during the course 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 compare the Oral Bioavailability of NovaSOL® Q 100 mg capsules, Kaneka Ubiquinol® 100 mg Capsules versus Native Coenzyme Q10 100 mg Capsules in healthy, Adult Human Subjects Under Fasting Conditions.   42 Days  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of test product comparing with the reference
product in healthy, adult, human subjects under Fasting conditions.  		 42 Days  
 
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   N/A 
Date of First Enrollment (India)   30/10/2025 
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="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   Coenzyme Q10 (CoQ10), also known as ubiquinone, is a fat-soluble, vitamin-like molecule naturally present in every cellular membrane within our bodies. This enzyme is a regular component of our diet, although it is also synthesized endogenously. CoQ10 is crucial for efficiently transferring electrons within the mitochondrial oxidative respiratory chain and producing adenosine triphosphate (ATP). Coenzyme Q10 (CoQ10) is a substance that helps convert food into energy. CoQ10 is found in almost every cell in the body, and it is a powerful antioxidant. CoQ10 can potentially increase the production of vital antioxidants, such as superoxide dismutase, an enzyme that effectively mitigates vascular oxidative stress in individuals with hypertension. In addition, CoQ10 lowers lipid peroxidation levels by diminishing pro-oxidative compounds. Furthermore, CoQ10 can improve blood flow and safeguard blood vessels by preserving nitric oxide.  
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