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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitaDry-CoQ10 | Experimental | VitaDry CoQ10 contains 100 mg of CoQ10 per serving. |
|
| VitaSperse-CoQ10 | Experimental | VitaSperse-CoQ10 contains 50 mg of CoQ10 per serving. |
|
| CoQ10 | Experimental | CoQ10 contains 50 mg of CoQ10 mg per serving. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in incremental AUC between three CoQ10 formulations | Difference in incremental AUC between three CoQ10 formulations from time 0 to infinity (AUC0-∞) | 0 hours to infinity post dose |
| Difference in AUC between three CoQ10 formulations |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 to 71 |
| Clinically relevant changes in blood pressure (BP) after supplementation |
Inclusion Criteria:
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:
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)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| 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. |
|
Difference in AUC between three CoQ10 formulations from time 0 to 72 hours (AUC0-72hr)
| 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 | 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 | 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 | 0 hours to tmax post dose |
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. |
| Day 0 to 71 |
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Day 0 to 71 |
| Clinically relevant changes in complete blood count after supplementation | Clinically relevant changes in complete blood count after supplementation | Day 0 to 71 |