CTRI/2025/10/096150Not yet recruitingNot Applicable
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.
Aquanova AG1 site in 1 country36 target enrollmentStarted: October 30, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 42 Days
Secondary Outcomes
- To monitor the safety and tolerability of test product comparing with the reference(product in healthy, adult, human subjects under Fasting conditions.)
Investigators
Dr Velavan Kandappan
Erode Cancer center
Study Sites (1)
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