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Trial record 61 of 742 for:    Area Under Curve AND Bioavailability

Bioavailability Study of COQUN ORAL FORMULATION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 23, 2019
First Posted Date  ICMJE January 28, 2019
Results First Submitted Date  ICMJE May 9, 2019
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE June 22, 2018
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Analysis of Pharmacokinetic Property "Area Under the Curve" [ Time Frame: Change at every visit (Day 0, Day 7, Day 14 and Day 28) versus baseline (Day -7) ]
    - Area under the curve (microg/ml x h): ≥5 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 90% level will be provided.
  • Analysis of Pharmacokinetic Property "Cmax" [ Time Frame: Change at every visit (Day 0, Day 7, Day 14 and Day 28) versus baseline (Day -7) ]
    - Cmax: ≥0,8 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 90% level will be provided.
  • Analysis of Pharmacokinetic Property "Tmax" [ Time Frame: Change at every visit (Day 0, Day 7, Day 14 and Day 28) versus baseline (Day -7) ]
    - Tmax: ≥3 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 90% level will be provided.
  • Analysis of pharmacokinetic property "elimination half-life" [ Time Frame: Change at every visit (Day 0, Day 7, Day 14 and Day 28) versus baseline (Day -7) ]
    - elimination half-life (t 1/2) Due to the explorative aim of the study, descriptive statistics and confidence intervals at 90% level will be provided.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of COQUN ORAL FORMULATION
Official Title  ICMJE Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Male & Female Healthy Volunteers
Intervention  ICMJE Dietary Supplement: COQUN ORAL FORMULATION
COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Study Arms  ICMJE
  • Experimental: Group A
    100 mg OD
    Intervention: Dietary Supplement: COQUN ORAL FORMULATION
  • Experimental: Group B
    100 mg BID
    Intervention: Dietary Supplement: COQUN ORAL FORMULATION
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 29, 2018
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819491
Other Study ID Numbers  ICMJE VF-BAQ10/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VISUfarma SpA
Study Sponsor  ICMJE VISUfarma SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VISUfarma SpA
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP