Male & Female Healthy VolunteersPhase 1NCT03819491
Bioavailability Study of COQUN ORAL FORMULATION
A Phase 1 study testing COQUN ORAL FORMULATION in people with Male & Female Healthy Volunteers, run by VISUfarma SpA at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Male & Female Healthy Volunteers
- What is being tested?
- COQUN ORAL FORMULATION
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRomania
- Study dates
- 22 Jun 2018to 29 Aug 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
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.
Read the 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.
- Conditions
- Male & Female Healthy Volunteers
- Being tested
- COQUN ORAL FORMULATION
- Keywords
- COQUN, antioxidant, Bioavailability, CoQ10, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COQUN ORAL FORMULATIONDietary supplement
COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 100 mg OD Receives: Dietary Supplement: COQUN ORAL FORMULATION |
| Group B | Experimental | 100 mg BID Receives: Dietary Supplement: COQUN ORAL FORMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from day-7 to day 28
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.
Measured: from day-7 to day 28
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.
Measured: from day-7 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start22 Jun 2018
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Male & Female Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819491
- Sponsor's protocol ID
- VF-BAQ10/2018
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2019
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
- ClinicalTrials.gov ID
- NCT03819491
- Acronym / sponsor ID
- VF-BAQ10/2018
- Conditions
- Male & Female Healthy Volunteers
- Keywords
- COQUN, antioxidant, Bioavailability, CoQ10, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: COQUN ORAL FORMULATION100 mg OD |
| Group B | Experimental | Dietary Supplement: COQUN ORAL FORMULATION100 mg BID |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COQUN ORAL FORMULATIONCOQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® | Dietary supplement | Group A, Group B |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COQUN ORAL FORMULATION in people with Male & Female Healthy Volunteers, run by VISUfarma SpA at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Pharmacokinetic Property "Area Under the Curve" (time frame: from day-7 to day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.