Bioavailability Study of COQUN ORAL FORMULATION
Condition: Male & Female Healthy Volunteers
Intervention: COQUN ORAL FORMULATION
Intervention description: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the best dosage between 100 mg OD or 100 mg BID for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COQUN; antioxidant; Bioavailability; CoQ10; Healthy

Summary:

      The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to
      reach a level of plasma concentration which might assure its antioxidant effect if taken on a
      regular basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject Informed consent form (ICF) is signed

          -  M & F Aged between 35-75 years at the time of the signature of ICF

          -  A body mass index between 20 and 29 kg/m2

          -  Fasting the night before enrolment, for at least 10 hours

          -  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 (standardized 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), and keeping
             a diary for the time of multiple-dose study (to follow their compliance and
             palatability)

        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

          -  Hypotension

          -  Any clinically significant history of serious digestive tract, liver, kidney,
             cardiovascular or hematological disease, diabetes

          -  Gastrointestinal disorders or other serious acute or chronic diseases

          -  Known lactose/gluten intolerances/ food allergies (limitation for standardization 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