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Bioavailability Study of COQUN ORAL FORMULATION

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ClinicalTrials.gov Identifier: NCT03819491
Recruitment Status : Completed
First Posted : January 28, 2019
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
VISUfarma SpA

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.

Condition or disease Intervention/treatment Phase
Male & Female Healthy Volunteers Dietary Supplement: COQUN ORAL FORMULATION Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


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®




Primary Outcome Measures :
  1. Analysis of Pharmacokinetic Property "Area Under the Curve" [ Time Frame: from day-7 to day 28 ]

    - 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.


  2. Analysis of Pharmacokinetic Property "Cmax" [ Time Frame: from day-7 to day 28 ]

    - 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.


  3. Analysis of Pharmacokinetic Property "Tmax" [ Time Frame: from day-7 to day 28 ]

    - 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.




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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819491


Locations
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Romania
Consult Med Iasi
Iasi, Iasi County, Romania, Romania, 550
Sponsors and Collaborators
VISUfarma SpA
  Study Documents (Full-Text)

Documents provided by VISUfarma SpA:
Study Protocol  [PDF] March 3, 2018
Statistical Analysis Plan  [PDF] September 3, 2018


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Responsible Party: VISUfarma SpA
ClinicalTrials.gov Identifier: NCT03819491     History of Changes
Other Study ID Numbers: VF-BAQ10/2018
First Posted: January 28, 2019    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VISUfarma SpA:
COQUN
antioxidant
Bioavailability
CoQ10
Healthy
Additional relevant MeSH terms:
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Coenzyme Q10
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs