Pharmacokinetic ParametersNCT07255079
A Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
A study testing VitaDry-Q10, VitaSperse-Q10 and Coenzyme Q10 in people with Pharmacokinetic Parameters and Bioavailability Heathy Volunteers, run by 3i Solutions at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pharmacokinetic Parameters, Bioavailability Heathy Volunteers
- What is being tested?
- VitaDry-Q10, VitaSperse-Q10 and Coenzyme Q10
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2026to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18 to 60 years of age, inclusive
- 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)
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- 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)
Who cannot join
- 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
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- 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
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of prescribed cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to Visit 2 or a blood donation of more than 450 mL within 56 days prior to Visit 2
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blinded, Comparator Controlled, Cross-over Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
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.
- Being tested
- VitaDry-Q10, VitaSperse-Q10, Coenzyme Q10
- Keywords
- pharmacokinetic, bioavailability, healthy volunteers, Coenzyme Q10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaDry-Q10Dietary 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.
VitaSperse-Q10Dietary 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.
Coenzyme Q10Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| VitaDry-CoQ10 | Experimental | VitaDry CoQ10 contains 100 mg of CoQ10 per serving. Receives: Dietary Supplement: VitaDry-Q10 |
| VitaSperse-CoQ10 | Experimental | VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving. Receives: Dietary Supplement: VitaSperse-Q10 |
| CoQ10 | Experimental | CoQ10 contains 50 mg of CoQ10 mg per serving. Receives: Dietary Supplement: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 to 72 hours post dose
Secondary outcomes (5)
Difference in incremental AUC between three CoQ10 formulations
Difference in incremental AUC between three CoQ10 formulations from time 0 to infinity (AUC0-∞)
Measured: 0 hours to infinity post dose
Difference in AUC between three CoQ10 formulations
Difference in AUC between three CoQ10 formulations from time 0 to 72 hours (AUC0-72hr)
Measured: 0 hours to 72 hours post dose
Difference in Maximum concentration (Cmax) between three CoQ10 formulations
Difference in Maximum concentration (Cmax) between three CoQ10 formulations
Measured: 0 hours to Cmax post dose
Difference in time to peak maximum concentration (tmax) between three CoQ10 formulations
Difference in time to peak maximum concentration (tmax) between three CoQ10 formulations
Measured: 0 hours to tmax post dose
Difference in half-life (t1/2) between three CoQ10 formulations
Difference in half-life (t1/2) between three CoQ10 formulations
Measured: 0 hours to tmax post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start3 Apr 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic ParametersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3i Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255079
- Sponsor's protocol ID
- 25IIIRR01
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Comparator Controlled, Cross-over Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
- ClinicalTrials.gov ID
- NCT07255079
- Acronym / sponsor ID
- 25IIIRR01
- Keywords
- pharmacokinetic, bioavailability, healthy volunteers, Coenzyme Q10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- 3i SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VitaDry-CoQ10 | Experimental | Dietary Supplement: VitaDry-Q10VitaDry CoQ10 contains 100 mg of CoQ10 per serving. |
| VitaSperse-CoQ10 | Experimental | Dietary Supplement: VitaSperse-Q10VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving. |
| CoQ10 | Experimental | Dietary Supplement: Coenzyme Q10CoQ10 contains 50 mg of CoQ10 mg per serving. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males and females 18 to 60 years of age, inclusive
- 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:
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaDry-Q10Participants consuming a capsule product will be required to consume 2 x 50mg capsules for a combined dose of 100mg with a cup of water. | Dietary supplement | VitaDry-CoQ10 |
| VitaSperse-Q10Participants consuming liquid product will be required to drink a cup of water following administration of 5 mL of study product delivered via syringe. | Dietary supplement | VitaSperse-CoQ10 |
| Coenzyme Q10Participants consuming a capsule product will be required to consume 2 x 50mg capsules for a combined dose of 100mg with a cup of water. | Dietary supplement | CoQ10 |
Primary outcome
Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC)
Time frame: 0 to 72 hours post dose
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)
5 secondary outcomes
Difference in incremental AUC between three CoQ10 formulations
Time frame: 0 hours to infinity post dose
Difference in AUC between three CoQ10 formulations
Time frame: 0 hours to 72 hours post dose
Difference in Maximum concentration (Cmax) between three CoQ10 formulations
Time frame: 0 hours to Cmax post dose
Difference in time to peak maximum concentration (tmax) between three CoQ10 formulations
Time frame: 0 hours to tmax post dose
Difference in half-life (t1/2) between three CoQ10 formulations
Time frame: 0 hours to tmax post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaDry-Q10, VitaSperse-Q10 and Coenzyme Q10 in people with Pharmacokinetic Parameters and Bioavailability Heathy Volunteers, run by 3i Solutions at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the bioavailability of three Coenzyme Q10 (CoQ10) formulations as assessed by the incremental area-under-the-curve (AUC) (time frame: 0 to 72 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.