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CTRI Number  CTRI/2026/01/100761 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial study in healthy volunteers 
Scientific Title of Study   Stage 1 Single Dose Study A Randomized, Open Label, Balanced, four Treatments, single period, Single Dose and , parallel, comparative bioavailability Study of Nanomicelle formulation of CoQ10, Test Product T UBISOL Q10 20mg per mL Oral liquid 5mL with reference product R1 Qunol Ultra CoQ10 100mg Soft gel Capsule, reference product R2 Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and reference product R3 CPM Coenzyme Q10 25mg per ml oil for intramuscular administration 4 mL in Healthy, Adult, Human Subjects under non fasting Condition.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Study Code-SY/25/18, Protocol Version No-01, Date-03/12/25   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Viral Patel 
Designation  Director 
Affiliation  Sycon Clinical Research Private Limited 
Address  5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, India.

Gandhinagar
GUJARAT
382421
India 
Phone  7935644895  
Fax    
Email  viralp@syconcro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandkishor Gameti 
Designation  Principal Investigator 
Affiliation  Principal Investigator 
Address  5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, India.

Gandhinagar
GUJARAT
382421
India 
Phone  7935644895  
Fax    
Email  nandkishorg@syconcro.com  
 
Details of Contact Person
Public Query  
Name  Viral Patel 
Designation  Director  
Affiliation  Sycon Clinical Research Private Limited 
Address  5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, India

Gandhinagar
GUJARAT
382421
India 
Phone  7935644895  
Fax    
Email  viralp@syconcro.com  
 
Source of Monetary or Material Support  
Micillic Lda Edificio Marina Club, Avenida Arriaga, No 73, 1o Andar, Sala 105 9004-533 Funchal, Portugal  
 
Primary Sponsor  
Name  Micillic Lda 
Address  Edificio Marina Club, Avenida Arriaga, No 73, 1o Andar, Sala 105 9004-533 Funchal, Portugal  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nandkishor Gameti  Sycon Clinical Research Private Limited  5th floor, Shree Sarju Arena, Opp. Kadi Nagrik Bank, Zundal, India.
Gandhinagar
GUJARAT 		 9879681692

nandkishorg@syconcro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Conscience Independent Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference product (R1): Qunol Ultra CoQ10 100mg Softgel  A single oral dose of one soft gel capsule (1 x 100 mg soft gel Capsule) Total duration-Single dose 
Comparator Agent  Reference product (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule   A single oral dose of one soft gel capsule (1 x 100 mg soft gel Capsule) Total duration-Single dose 
Comparator Agent  Reference product (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration   A single dose of CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) Total duration-Single dose 
Intervention  Test product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL)  A single oral dose of 5 mL, Total duration-Single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Healthy human subjects (Male and female), age in the range of 18-50 years both inclusive.
Body Mass Index between 18.5-29.9 Kg / m2 extremes included with a minimum of 48 kg weight.
Subjects with normal findings as determined by baseline history, physical examination and vital sign examination.
Subjects with clinically acceptable findings as determined by haemogram, Lipid Profile test, biochemistry, urinalysis, urine pregnancy test (for female subjects only) and 12 lead ECG.
Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in study period and adherence to all study
restrictions.
Willing to accurately fill a food diary during the duration of the study.
No history of significant alcoholism.
No history of drug abuse (benzodiazepines and barbiturates) for the last one month and
other illegal drugs for the last 06 months.
Non-smokers as evident from the history obtained.
Willing to provide written informed consent to participate in the study (In the case of
illiterate, informed consent will be taken in presence of impartial witness).
Subjects willing to use acceptable birth control measures (abstinence, barrier methods like
condom with spermicidal jelly etc.) throughout the study duration.
Healthy individuals, not taking prescription medications for at least a month prior to the
start of enrolment for the study and during the study.
Willing to provide written informed consent to participate in the study (In the case of illerate,
informed consent will be taken in presence of impartial witness).
Fasting the night before enrolment for at least 12.00 hrs.
 
 
ExclusionCriteria 
Details  Known history of hypersensitivity to Jamieson CoQ10 or related drugs or any of the excipients.
Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days prior to dosing day.
Subjects who have taken prescription medications or over the counter products (including vitamins and minerals) within 14 days prior to administration of IP.
Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
Participation in a clinical drug study or Bioavailability study within 90 days prior to Period- I dosing of the present study.
Not eligible as per Online Volunteer Information System (OVIS).
Volunteer who have donated blood or experienced loss of blood of up to 150 ml within 30 days or in between 150 ml to 250 ml within 60 days or more than 250 ml within 90 days (exclude blood loss for screening) prior to first dose of study.
History of malignancy or other serious diseases.
Subjects with positive result of HIV tests or HBsAg or Hepatitis C tests during screening.
Found positive in breath alcohol test and/or urine test for drug abuse.
History of problems in swallowing of tablet/capsule.
Any contraindication to blood sampling.
Male human subjects not willing to use birth control measures, from the period-I dosing until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
Subjects with a history of taking Statin drugs that will affect Q10 level.
Subjects taking supplements of Q10 for at least four weeks prior to the check in or other vitamin supplements for at least two weeks prior to check in.
Use of hormonal contraceptives either oral or implants.
Taking any prescribed medication including coumadin warfarin within 4 weeks of
enrolment into the study.
Taking any food supplements especially supplements containing Coenzyme Q10 within 4
weeks of enrolment into the study, except vitamin D and calcium.
Regular drug and/or alcohol abuse; using any form of nicotine or tobacco, mental incapacity
that may prevent adequate understanding or cooperation of the participation in the study as assessed by the study screener.
Female subjects found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.
Lactating women (currently breast feeding).
Female subjects not confirming to using birth control measures, from the date of screeninguntil the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the comparative bioavailability Study between Test
Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1):
Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition
before the pre-dose (-02.00 hour)
blood sample collection and keep up to 23.00 hrs post-dose (Dosing
day 01 and dosing day 10) if possible 		 Collection of the blood samples before the pre-dose (-02.00 hour)
blood sample collection and keep up to 23.00 hrs post-dose (Dosing
day 01 and dosing day 10) if possible.
For dosing day 02 to Dosing day 09 blood sample will be collected
through the fresh vein puncher
Product (T): UBISOL- Q10® (20mg/mL) Oral liquid (5mL) with reference product (R1):
Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy, adult, human subjects under non fasting condition
before the pre-dose (-02.00 hour)
blood sample collection and keep up to 23.00 hrs post-dose (Dosing
day 01 and dosing day 10) if possible 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single & multiple dose
of investigational medicinal products (IMPs).
 		 Pre dose-Well-being assessment, measurement of blood pressure,oral
temperature and pulse rate (within 03.00 hour prior to dosing) on day 01
to day 10
Post dose-Well-being assessment, blood pressure and pulse rate (on all the dosing
days).
Post-dose vitals at 03.00, 06.00, and 13.00 hrs. ± 40 minutes of scheduled
time will be measured on all the dosing day 1 to day 10.
Checkout-Well-being assessment, physical examination and vital signs
measurement (blood pressure, pulse rate, and oral temperature).
Physical examination and vital examination can be started
approximately 03.00 hours prior to the scheduled time in study
period. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   26/01/2026 
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)   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  

Ubiquinol (CoQ10) is safe as a dietary supplement and indicated for heart failure, high blood pressure, gum disease, Parkinson disease, blood infections, certain diseases of the muscles, fibromyalgia, diabetes and HIV infection.

This present study will be conducted in compliance with the protocol approved by the Ethics Committee (EC) and according to Good Clinical Practice (GCP) standards. The primary objective of the study to evaluate and demonstrate single dose, comparative Bioavailability of test product; UBISOL- Q10® (20mg/mL) Oral liquid with the already available marketed product (R1):Qunol Ultra CoQ10 100mg Soft gel Capsule, (R2): Kirkland Signature CoQ10 100 mg Enteric coated Soft gel Capsule and (R3): CPM Coenzyme Q10 25mg/ml oil for intramuscular administration (4 mL) in healthy adult human subjects under non fasting condition.

Also To demonstrate the Multiple Dose, parallel, comparative steady

state bioavailability between Test Product (T1): 5 mL of UBISOL-Q10 (20mg/mL) with Test product (T2): 10 mL of UBISOL-Q10 (20mg/mL), Test product (T3): 20 mL of UBISOL-Q10 (20mg/mL) and Test product (T4): 25 mL of UBISOL-Q10 (20mg/mL) in healthy, adult, human subjects under non fasting condition.

 
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