Status:
COMPLETED
Bioavailability Study of COQUN ORAL FORMULATION
Lead Sponsor:
VISUfarma SpA
Conditions:
Male & Female Healthy Volunteers
Eligibility:
All Genders
25-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24 subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which will be followed by a o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03819491
Start Date
June 22 2018
End Date
August 29 2018
Last Update
September 6 2019
Active Locations (1)
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1
Consult Med Iasi
Iași, Iasi County, Romania, Romania, 550