Male & Female Healthy Volunteers
Conditions
Keywords
COQUN, antioxidant, Bioavailability, CoQ10, Healthy
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.
Interventions
DIETARY_SUPPLEMENTCOQUN ORAL FORMULATION
COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Sponsors
VISUfarma SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Pharmacokinetic Property Area Under the Curve | 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 | 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 | 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. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoQ10 Once Daily 100 mg OD
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® | 12 |
| CoQ10 Twice a Day 100 mg BID
COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | CoQ10 Twice a Day | Total | CoQ10 Once Daily |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 7 | 39 years STANDARD_DEVIATION 7 | 35 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 24 |
| other Total, other adverse events | 0 / 12 | 3 / 12 | 0 / 24 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 24 |
Outcome results
Primary
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.
Time frame: from day-7 to day 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CoQ10 Once Daily | Analysis of Pharmacokinetic Property Area Under the Curve | 2657.45 microg/l*days |
| CoQ10 Twice a Day | Analysis of Pharmacokinetic Property Area Under the Curve | 3459.05 microg/l*days |
Primary
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.
Time frame: from day-7 to day 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CoQ10 Once Daily | Analysis of Pharmacokinetic Property Cmax | 1163.99 microg/l |
| CoQ10 Twice a Day | Analysis of Pharmacokinetic Property Cmax | 1501.89 microg/l |
Primary
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.
Time frame: from day-7 to day 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CoQ10 Once Daily | Analysis of Pharmacokinetic Property Tmax | 17.5 hours |
| CoQ10 Twice a Day | Analysis of Pharmacokinetic Property Tmax | 16.92 hours |