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Phase 1 N=24 Randomized Other

Bioavailability Study of COQUN ORAL FORMULATION

Male & Female Healthy Volunteers

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Analysis of Pharmacokinetic Property "Area Under the Curve" — 2657.45; 3459.05 microg/l*days

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
COQUN ORAL FORMULATION (Dietary_supplement)
Age
Adult, Older Adult · 25+ yrs
Sex
All
Sponsor
VISUfarma SpA
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Analysis of Pharmacokinetic Property "Area Under the Curve"
2657.45; 3459.05
PRIMARY
Analysis of Pharmacokinetic Property "Cmax"
1163.99; 1501.89
PRIMARY
Analysis of Pharmacokinetic Property "Tmax"
17.5; 16.92

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03819491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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