| CTRI Number |
CTRI/2024/01/061606 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial study in healthy volunteers |
|
Scientific Title of Study
|
An open label, single arm, pilot study to determine the bioavailability of Liposomal CoQ-10 in three (3 no) healthy human volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/COQ/02/BA/2023 Version Number: 1.0 Dated: 12-Dec-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
#99/A, 8th Main road, III Phase Peenya Industrial Area, Bangalore
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
#99/A, 8th Main road, III Phase Peenya Industrial Area, Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt. Ltd |
| Address |
#99/A, 8th Main road, III Phase Peenya Industrial Area, Bangalore
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 ingredient supplier] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambrish C |
Medstar Speciality Hospital |
641,17,1,3, Medstar Speciality Hospital, Kodigehalli Main Road, Sahakarnagar, Bangalore 560092, Karnataka, India.
Bangalore
KARNATAKA |
9845895911
drambrishmedstar@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Liposomal CoQ-10 |
Route of administration: Oral Dosage form: Tablet
Dose: 100mg
Duration:1 day |
| Comparator Agent |
Nil |
Nil |
|
|
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 or 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 in the last month.
3.Subject with resting hypotension (BP less than 90 to 60) or hypertension (BP greater than 140 to 90) and pulse rate below 50 per min and more than 100 per 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the bioavailability of CoQ-10 in liposomal CoQ-10 formulations |
0min, 30min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12 hr and 24hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this study is to monitor the safety and tolerability of a single dose of liposomal CoQ-10 formulations. |
Day 0 and Day 1 |
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2024 |
| Date of Study Completion (India) |
19/05/2024 |
| 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. After obtaining the Ethics committee approval subjects will
be asked to visit the site. After taking a written informed consent from the
healthy subject’s, they will be asked about their medical history and the
Investigator or his/her designee will conduct a physical examination.
Demographics and vital signs will be recorded. Blood sample will be drawn from
each subject for analysis of haematology, biochemistry and virology. X-ray and
ECG will be performed. Subjects will be
enrolled into the study after all the IC/EC criteria are met. They will be asked to report to the site after 7 days. They
will be in-housed into the facility. Physical examination will be conducted.
Vitals will be recorded. They will be asked for overnight fasting for at least
10 hours On the day of dosing, physical examination along will be
performed. Vitals will be recorded. An indwelling IV cannula/scalp vein will be
placed in-situ on a forearm vein of the subjects till 12 hours. Blood samples
will be drawn for pharmacokinetic analysis on these time period 0hrs will be
before the dosing. Vitals will be recorded at this time along with physical
examination. On the day of the study, phlebotomy will be performed within
01 hours prior to dosing. An indwelling IV cannula/scalp vein will be placed
in-situ of a forearm vein of the subjects till 12 hours. Subsequent samples
after 12.00 hrs. will be drawn by fresh direct venipuncture. After dosing these
will be the time points of blood sampling, 0min, 30min, 60min, 90min, 120min,
3hr, 4hr, 6hr, 8hr, 12 hr and 24hrs. Vitals will be recorded at these time points, 0min, 30min,
60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12 hr and post-dose and at the time
of checkout (24.00 hrs). The subject will be allowed to leave the facility after 24
hrs of dosing. Physical examination along with Vitals will be performed. Blood
sample will be drawn for analysis of hematology and biochemistry. The subject
will leave the facility after all the procedures have been conducted.
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