A Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults

NCT07255079 | Not Yet Recruiting

• 1 other identifier: 25IIIRR01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the pharmacokinetic profile of three Coenzyme Q10 formulations in healthy adults. The main question it aims to answer is: What is the difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC) from time 0 to the last measured timepoint (AUC0-72hr)? Participants will be asked to consume three formulations of CoQ10 and will be evaluated for CoQ10 levels in blood, over a 71-day period.

Conditions

Pharmacokinetic Parameters; Bioavailability Heathy Volunteers

Keywords

pharmacokinetic; bioavailability; healthy volunteers; Coenzyme Q10

Outcome Measures

Primary Outcomes (1)

• Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC)

  Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC) from time 0 to the last measured timepoint (AUC0-72hr)

  0 to 72 hours post dose

Secondary Outcomes (5)

• Difference in incremental AUC between three CoQ10 formulations

  0 hours to infinity post dose

• Difference in AUC between three CoQ10 formulations

  0 hours to 72 hours post dose

• Difference in Maximum concentration (Cmax) between three CoQ10 formulations

  0 hours to Cmax post dose

• Difference in time to peak maximum concentration (tmax) between three CoQ10 formulations

  0 hours to tmax post dose

• Difference in half-life (t1/2) between three CoQ10 formulations

  0 hours to tmax post dose

Other Outcomes (4)

• Clinically relevant changes in heart rate after supplementation.

  Day 0 to 71

• Clinically relevant changes in blood pressure (BP) after supplementation

  Day 0 to 71

• Incidence of post-emergent adverse events (AE)

  Day 0 to 71

Study Arms (3)

VitaDry-CoQ10

EXPERIMENTAL

VitaDry CoQ10 contains 100 mg of CoQ10 per serving.

Dietary Supplement: VitaDry-Q10

VitaSperse-CoQ10

EXPERIMENTAL

VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving.

Dietary Supplement: VitaSperse-Q10

CoQ10

EXPERIMENTAL

CoQ10 contains 50 mg of CoQ10 mg per serving.

Dietary Supplement: Coenzyme Q10

Interventions

VitaDry-Q10 DIETARY_SUPPLEMENT

Participants consuming a capsule product will be required to consume 2 x 50mg capsules for a combined dose of 100mg with a cup of water.

VitaDry-CoQ10

VitaSperse-Q10 DIETARY_SUPPLEMENT

Participants consuming liquid product will be required to drink a cup of water following administration of 5 mL of study product delivered via syringe.

VitaSperse-CoQ10

Coenzyme Q10 DIETARY_SUPPLEMENT

Participants consuming a capsule product will be required to consume 2 x 50mg capsules for a combined dose of 100mg with a cup of water.

CoQ10

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age
• BMI between 18.5 to 29.9 Kg/m3, inclusive
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
• Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Willingness to complete questionnaires and diaries associated with the study and complete all study requirements
• Agrees to maintain current lifestyle (diet, physical activity, medications, supplements, and sleep) as much as possible within study specific requirements throughout the study
• Provided voluntary, written, informed consent to participate in the study
• Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Poor venous access, as assessed by the QI
• Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products or comparator ingredients or inability to consume the standardized meals
• Following a specific diet (e.g. vegetarian, carnivore, paleo, vegan, etc.…)
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Type I or Type II diabetes
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI

Sponsors & Collaborators

• 3i Solutions: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

MeSH Terms

Interventions

coenzyme Q10

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: November 28, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CA (1)