Phase 1
N=24
Bioavailability Study of COQUN ORAL FORMULATION
Male & Female Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03819491 ↗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
| Outcome | Result | p-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
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.