Clinical trial NCT03819491: Bioavailability Study of COQUN ORAL FORMULATION
Official title: Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Male & Female Healthy Volunteers
Keywords: COQUN
antioxidant
Bioavailability
CoQ10
Healthy
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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 one week wash-out period and then by a 4 week period of continuous administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided in the continuous treatment period into two groups, one group of 12 patients with intake of 100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess multiple-dose profile of COQUN ORAL FORMULATION.

Patients will have to fast the night before enrolment, for at least 10 hours. Patients will be requested to fill in a short diary in the multidose phase, on a daily basis, for confirming the product correct intake, and informing on any experienced adverse event and eventual medication taken for its solving.

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

Primary outcomes:
measure: Analysis of Pharmacokinetic Property "Area Under the Curve"
timeFrame: from day-7 to day 28
measure: Analysis of Pharmacokinetic Property "Cmax"
timeFrame: from day-7 to day 28
measure: Analysis of Pharmacokinetic Property "Tmax"
timeFrame: from day-7 to day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Consult Med Iasi
state: Iasi County, Romania
Study officials:
References: