FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066483 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Bioavailability study on Healthy subjects  
Scientific Title of Study   A randomized, double blind, placebo controlled, three arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal CoQ-10 formulations in plasma in healthy volunteers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/BA/CoQ1/2024 Version Number :1.0 Date 20th March 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase,Peenya Industrial Area, Bengaluru, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase,Peenya Industrial Area, Bengaluru, Karnataka, India.


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase,Peenya Industrial Area, Bengaluru, Karnataka, India.


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
SPECNOVA LLC,102 NE 2nd Street #283, Boca Raton, FL 33432, U.S.A 
 
Primary Sponsor  
Name  SPECNOVA LLC 
Address  102 NE 2nd Street #283, Boca Raton, FL 33432, U.S.A 
Type of Sponsor  Other [Dietary supplement compny] 
 
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 
DrAmbrish C  Medstar Speciality Hospital  641/17/1/3, Medstar Speciality Hospital, Ground floor Room number 3 Kodigehalli Main Rd, Shanthivana, Sahakarnagar,Bengaluru, Karnataka
Bangalore
KARNATAKA 		 9611934655

drambrishc.medstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bioavailability study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose: 100 mg Dosage form: Capsules Frequency: Period I: single dose Wash out period: 5 Days Period 2: single dose Wash out period: 5 Days Period 3: single dose 
Intervention  Test Arm 1:Liposomal CoQ-10  Dose: 100 mg Dosage form: Capsules Frequency: Period I: single dose Wash out period: 5 Days Period 2: single dose Wash out period: 5 Days Period 3: single dose  
Intervention  Test Arm 2:Non-liposomal CoQ-10  Dose: 100 mg Dosage form: Capsules Frequency: Period I: single dose Wash out period: 5 Days Period 2: single dose Wash out period: 5 Days Period 3: single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects must be healthy human male and female (non-pregnant)
subjects.
2. Age should be between 18-45 years of age (both inclusive), weighing at
least 50 kg.
3. Subject who are ready to provide written informed consent and should
be willing to be available throughout the study duration and should follow
the guidelines mentioned in the protocol.
4. Subjects with no evidence of underlying disease during the pre-study
screening. They must be healthy as determined by medical history and
physical examination, ECG, Chest X-ray (PA View) and laboratory tests
performed within 7 days prior to the commencement of the study.
5. Subjects whose screening laboratory values are within normal limits or
considered by the physician / Principal Investigator to be of no clinical
significance 
 
ExclusionCriteria 
Details  1. Subjects who are allergic to CoQ 10 products or any food or other drugs.
2. Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month.
3. Subject with resting hypotension (BP 140 /90) and pulse rate below 50/min and more than 100/min.
4. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
5. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
6. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
7. Subject who has a history of alcoholism, drug abuse or Smoking.
8. Subjects who are hypersensitive to Heparin
9. Subjects who participated in any other clinical study in the past three months.
10. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X ray (PA View).
11. Subject who has difficulty with donating blood.
12. Subject with history of difficulty in swallowing.
13. Subject who has unsuitable veins for repeated venipuncture.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To determine the bioavailability of CoQ-10 in liposomal and non-liposomal formulations in plasma by LCMS/HPLC  0min, 30min, 60min,
90min, 120min, 3hr, 4hr, 6hr, 8hr, 12hr and 24hrs for period 1,2 and 3 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the changes in biomarkers – CRP, MDA,
Serum anti-oxidant capacity (Glutathione Peroxidase-1,
GPx-1), TNF alpha
2. To monitor the safety and tolerability of a single dose of liposomal CoQ-10 formulations by reviewing adverse events. 		 Day 0 to End of the study  
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/05/2024 
Date of Study Completion (India) 05/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Liposomal CoQ-10 is basically CoQ-10 in a liposome. Coenzyme Q10 (CoQ-10), ubiquinone, is an endogenous lipophilic benzoquinone compound which acts as an electron transport in the respiratory chain of the mammalian mitochondrial membrane. Over the last few years, CoQ-10 gained significant research attention as a dietary supplement used for generating cellular bioenergy and preventing tissue damage caused by oxidative stress. 1 However, only a very small percentage of orally administered crystalline CoQ-10 is taken up in the blood stream, making the treatment of CoQ10 deficiencies difficult. Due to the hydrophobic nature of CoQ-10, the use of a liposomal carrier for the delivery might be possible. Since CoQ-10 is largely located in the inner mitochondrial membrane, a mitochondrial-targeted delivery system will be needed. 
Close