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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 100 mg OD |
|
| Group B | Experimental | 100 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COQUN ORAL FORMULATION | Dietary Supplement | COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | from day-7 to day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consult Med Iasi | Iași | Iasi County, Romania | 550 | Romania |
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| ID | Title | Description |
|---|---|---|
| FG000 | CoQ10 Once Daily | 100 mg OD COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
| FG001 | CoQ10 Twice a Day | 100 mg BID COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before Randomization |
| |||||||||||||
| After Randomization |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CoQ10 Once Daily | 100 mg OD COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
| BG001 | CoQ10 Twice a Day | 100 mg BID COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | microg/l*days | from day-7 to day 28 |
|
AE were collected for the total duration of the study (28 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CoQ10 Once Daily After Randomization | 100 mg OD COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIZZINESS | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Delia Reurean-Pintilei | Consult Med Iasi | +40232233387 | drdeliapintilei@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2018 | May 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2018 | Jul 23, 2019 | SAP_001.pdf |
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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.
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | microg/l | from day-7 to day 28 |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | hours | from day-7 to day 28 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | CoQ10 Twice a Day After Randomization | 100 mg BID COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | CoQ10 Once Daily Before Randomization | 100 mg OD COQUN ORAL FORMULATION: COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES® | 0 | 24 | 0 | 24 | 0 | 24 |
| RESPIRATORY VIROSIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PULTACEOUS ANGINA | Cardiac disorders | Non-systematic Assessment |
|
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