Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

Study Overview
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Brief Summary
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The single-center, randomized, open-label, five-period crossover single-dose bioavailability study with five CoQ10 formulations

Detailed Description
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The single-center, randomized, open-label, five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Study will be conducted with single dose CoQ10 to assess bioavailability.

Official Title
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Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations in Healthy Adults

Conditions
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Bioavailability of Coenzyme Q10

Intervention / Treatment
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* Dietary Supplement: Single dose intervention with Standard product (SP)
* Dietary Supplement: Single dose intervention with Investigational product (IP1)
* Dietary Supplement: Single dose intervention with Investigational product (IP2)
* Dietary Supplement: Single dose intervention with Investigational product (IP3)
* Dietary Supplement: Single dose intervention with Investigational product (IP4)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject Informed consent form (ICF) is singed Aged between 18 and 65 years at the time of the signature of ICF A body mass index between 18.5-29.9 kg/m2 Total blood cholesterol range 3,11 - 6,50 mmol/L (not treated with medications) Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread) Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling) Exclusion criteria: Intake of any prescribed medication within 2 weeks of the beginning of the study Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium Pregnancy or planned pregnancy Breast-feeding mother Hypotension Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or haematological disease, diabetes Gastrointestinal disorders or other serious acute or chronic diseases Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals) Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal Known drug and/or alcohol abuse Using any form of nicotine or tobacco Mental incapacity that precludes adequate understanding or cooperation Participation in another investigational study or blood donation within 3 months prior to or during this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Five-period crossover bioavailability study will include 30 subjects who will test five CoQ10 formulations. Subjects will test 5 formulations of single dose CoQ10 with 2 week wash-out. to assess bioavailability.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard product (SP): USP CoQ10 powder, hard capsules<br>100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 | Dietary Supplement: Single dose intervention with Standard product (SP)<br>* 2 capsules - 200 mg total CoQ10<br>|
| Experimental: Investigational product 1 (IP1): CoQ10 in soybean oil, softgels<br>100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 | Dietary Supplement: Single dose intervention with Investigational product (IP1)<br>* 2 softgels - 200 mg total CoQ10<br>|
| Experimental: Investigational product 2 (IP2): Q-Gel hydrosoluble/bioenhanced CoQ10, softgels<br>100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 | Dietary Supplement: Single dose intervention with Investigational product (IP2)<br>* 2 softgels - 200 mg total CoQ10<br>|
| Experimental: Investigational product 3 (IP3): Qunol Mega Ubiquinol, softgels<br>100 mg per softgel; dosage: 2 softgels - 200 mg total CoQ10 | Dietary Supplement: Single dose intervention with Investigational product (IP3)<br>* 2 softgels - 200 mg total CoQ10<br>|
| Experimental: Investigational product 4 (IP4): HydroQsorb Coenzyme Q10, hard capsules<br>100 mg per capsule; dosage: 2 capsules - 200 mg total CoQ10 | Dietary Supplement: Single dose intervention with Investigational product (IP4)<br>* 2 capsules - 200 mg total CoQ10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative single dose bioavailability (AUC48) of IP (in comparison to SP) | Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUC0-72h, i.e. area under the plasma concentration curve from the administration time to the last observation point (72h) of CoQ10 plasma concentrations above the baseline value. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative single dose bioavailability (AUCinf) of IP (in comparison to SP) | Relative bioavailability between the investigational products and the standard product (IP1 vs. SP, IP2 vs. SP, IP3 vs. SP, and IP4 vs. SP) expressed as ratio of baseline corrected AUCinf, i.e. extrapolated area under the CoQ10 plasma concentration curve above the baseline CoQ10 concentration. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coenzyme q10, single dose bioavailability