Health TrialsbyHealthPanel

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

ConditionsPharmacokinetic ParametersBioavailability Heathy Volunteers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
Sponsor3i Solutions

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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)

Disqualifiers

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.…)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: VitaDry-CoQ10Experimental treatment 1 intervention
Group B: VitaSperse-CoQ10Experimental treatment 1 intervention
Group C: CoQ10Experimental treatment 1 intervention

Trial outcomes

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)

Time frame
0 to 72 hours post dose

Secondary outcomes

1

Difference in incremental AUC between three CoQ10 formulations

Difference in incremental AUC between three CoQ10 formulations from time 0 to infinity (AUC0-∞)

Time frame
0 hours to infinity post dose
2

Difference in AUC between three CoQ10 formulations

Difference in AUC between three CoQ10 formulations from time 0 to 72 hours (AUC0-72hr)

Time frame
0 hours to 72 hours post dose
3

Difference in Maximum concentration (Cmax) between three CoQ10 formulations

Difference in Maximum concentration (Cmax) between three CoQ10 formulations

Time frame
0 hours to Cmax post dose
4

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

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

Time frame
0 hours to tmax post dose

Other outcomes

1

Clinically relevant changes in heart rate after supplementation.

Clinically relevant changes in heart rate after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.

Time frame
Day 0 to 71
2

Clinically relevant changes in blood pressure (BP) after supplementation

Clinically relevant changes in heart rate after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.

Time frame
Day 0 to 71
3

Incidence of post-emergent adverse events (AE)

Incidence of post-emergent adverse events (AE)

Time frame
Day 0 to 71
4

Clinically relevant changes in complete blood count after supplementation

Clinically relevant changes in complete blood count after supplementation

Time frame
Day 0 to 71

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3i Solutions

Lead sponsor

KGK Science Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: