Comparative Single-dose Bioavailability Study of Different CoQ10 Formulations

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

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

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.

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