Bioavailability Study of COQUN ORAL FORMULATION

Male & Female Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819491
• Other study ID #: VF-BAQ10/2018
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2018
• Est. completion date: August 29, 2018

Study information

• Verified date: July 2019
• Source: VISUfarma SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Male & Female Healthy Volunteers

Intervention

Dietary Supplement:
• COQUN ORAL FORMULATION
COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Locations

Country	Name	City	State
Romania	Consult Med Iasi	Iasi	Iasi County, Romania

Sponsors (1)

Lead Sponsor	Collaborator
VISUfarma SpA

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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