Bioavailability Study of COQUN ORAL FORMULATION

NCT03819491 | Completed Phase 1 Results

• 1 other identifier: VF-BAQ10/2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Male & Female Healthy Volunteers

Keywords

COQUN; antioxidant; Bioavailability; CoQ10; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

100 mg OD

Dietary Supplement: COQUN ORAL FORMULATION

Group B

EXPERIMENTAL

100 mg BID

Dietary Supplement: COQUN ORAL FORMULATION

Interventions

COQUN ORAL FORMULATION DIETARY_SUPPLEMENT

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

Group A; Group B

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VISUfarma SpA: lead

Study Sites (1)

Consult Med Iasi

Iași, Iasi County, Romania, 550, Romania

Location

Results Point of Contact

• Title: Dr. Delia Reurean-Pintilei
• Organization: Consult Med Iasi

drdeliapintilei@gmail.com

+40232233387

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: June 22, 2018
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)