Bioavailability Study of COQUN ORAL FORMULATION

NCT ID: NCT03819491

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2018-08-29

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.

Conditions

Male & Female Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

100 mg OD

Group Type: EXPERIMENTAL

COQUN ORAL FORMULATION

Intervention Type: DIETARY_SUPPLEMENT

COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Group B

100 mg BID

Group Type: EXPERIMENTAL

COQUN ORAL FORMULATION

Intervention Type: DIETARY_SUPPLEMENT

COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Interventions

COQUN ORAL FORMULATION

COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VISUfarma SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Consult Med Iasi

Iași, Iasi County, Romania, Romania

Countries

Romania

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VF-BAQ10/2018

Identifier Type: -

Identifier Source: org_study_id