Bioavailability Study of COQUN ORAL FORMULATION

Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)

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.

Study Overview

• Status: Completed
• Conditions: Male & Female Healthy Volunteers
• Intervention / Treatment: Dietary supplement: COQUN ORAL FORMULATION

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Romania
  • Iasi County, Romania
    • Iasi, Iasi County, Romania, Romania, 550
      • Consult Med Iasi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 100 mg OD	Dietary supplement: COQUN ORAL FORMULATION; COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Experimental: Group B; 100 mg BID	Dietary supplement: COQUN ORAL FORMULATION; COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Pharmacokinetic Property "Area Under the Curve"	- Area under the curve (microg/ml x h): ≥5 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.	from day-7 to day 28
Analysis of Pharmacokinetic Property "Cmax"	- Cmax: ≥0,8 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.	from day-7 to day 28
Analysis of Pharmacokinetic Property "Tmax"	- Tmax: ≥3 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.	from day-7 to day 28

Collaborators and Investigators

• Sponsor: VISUfarma SpA

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): August 29, 2018

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Healthy; Bioavailability; CoQ10; antioxidant; COQUN
• Other Study ID Numbers: VF-BAQ10/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No