This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Bioavailability Study of COQUN ORAL FORMULATION (NCT03819491), a randomized phase 1 study. The primary outcome is Analysis of Pharmacokinetic Property "Area Under the Curve".
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03819491 |
| Phase | Phase 1 |
| Condition | Male & Female Healthy Volunteers |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | 2 |
| Lead sponsor | VISUfarma SpA |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled male and female healthy volunteers. The registry record reports an enrollment of 24 participants. It does not report further eligibility details, such as age limits or health-screening criteria, so the population should be understood only at the level described in the record: healthy adults.
Intervention
The intervention was COQUN oral formulation, identified as CoQ10 and classified in the registry as a dietary supplement. One randomized group received 100 mg once daily, described as 100 mg OD. The other received 100 mg twice daily, described as 100 mg BID. The record does not describe additional formulation or administration details.
Comparator
The once-daily regimen is the comparator for the twice-daily regimen in the two-arm primary outcome display. Both groups received the named COQUN formulation; the comparison concerns dosing frequency rather than a different active treatment or a placebo. The registry identifies a parallel-group randomized design and does not report the method used to generate or conceal the allocation.
Primary question
The study asked how the mean area under the curve, a pharmacokinetic measure of concentration over time, differed descriptively between the two dosing regimens. The stated aim was to evaluate a dosage intended to reach a plasma concentration that might assure an antioxidant effect with regular use. That aim is not itself evidence of an antioxidant effect or a clinical benefit: the posted primary outcome is pharmacokinetic, and the registry record does not report a formal between-group test.
3. Trial Design
This was a randomized, open-label, parallel-group Phase 1 study of COQUN oral formulation (CoQ10) in healthy adults. The registry reports enrollment of 24 participants and describes two groups: CoQ10 once daily at 100 mg OD and CoQ10 twice a day at 100 mg BID. Each group has 12 participants in the posted primary outcome summary. In a parallel design, participants are assigned to one regimen rather than crossing between regimens; the registry identifies this model but does not describe the allocation procedure in further detail.
The study is marked completed. The recorded start date is 2018-06-22, and the primary completion date is 2018-08-29. VISUfarma SpA is listed as the sponsor. The study has no masking, so it is described as open-label. The registry record does not report whether outcome assessment involved any additional safeguards against knowledge of treatment assignment.
The primary outcome is titled analysis of pharmacokinetic property “Area Under the Curve.” Its timeframe is from day-7 to day 28. The description states that concentration data were collected at 1, 2, 4, 8 and 12 hours after intake during the single-dose period on day -7 and at each following ambulatory visit. The record describes a mean with a 95% confidence interval and says that, because the study had an explorative aim, descriptive statistics and confidence intervals would be provided.
The registry lists three outcome measures but no posted secondary outcomes, and it lists no analysis records. It does not report the sample-size justification, a detailed statistical analysis plan, or the method of randomization. Those omissions limit what can be said about the planned confirmatory framework; the study should be read as an exploratory pharmacokinetic comparison with descriptive results rather than as a reported test of superiority.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before Randomization
| Stage | CoQ10 Once Daily | CoQ10 Twice a Day |
|---|---|---|
| STARTED | 24 | 0 |
| COMPLETED | 24 | 0 |
| NOT COMPLETED | 0 | 0 |
After Randomization
| Stage | CoQ10 Once Daily | CoQ10 Twice a Day |
|---|---|---|
| STARTED | 12 | 12 |
| COMPLETED | 12 | 12 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | CoQ10 Once Daily | CoQ10 Twice a Day | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 12 | 24 | |
| Age, Continuous | years | 35 (SD 7) | 43 (SD 7) | 39 (SD 7) |
| Sex: Female, Male: Female | Participants | 8 | 8 | 16 |
| Sex: Female, Male: Male | Participants | 4 | 4 | 8 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 12 | 12 | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Analysis of Pharmacokinetic Property "Area Under the Curve", measured over from day-7 to day 28.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | microg/l*days |
| Endpoint classification | Continuous Endpoint |
Area under the curve (AUC) is a pharmacokinetic summary that represents concentration accumulated across a period of time. In general, it combines information about the measured concentration and the duration over which it is observed. It is used to describe systemic exposure to a substance, rather than a clinical outcome such as symptom change or prevention of illness. In this study, the registry identifies AUC as the primary endpoint and reports group means with 95% confidence intervals.
The outcome description says “Area under the curve (microg/ml x h): ≥5,” while the endpoint unit field gives microg/l*days. These are different unit expressions in the registry record; it does not explain their relationship or identify which expression governs interpretation. The record also does not clarify whether ≥5 is a target, criterion, or another element of the endpoint description. Therefore, the listed threshold should not be treated as proof that either group reached a defined exposure goal.
Sampling was described at 1, 2, 4, 8 and 12 hours after intake on day -7, with additional measurements at subsequent ambulatory visits through the stated timeframe from day-7 to day 28. AUC is useful for integrating repeated concentration measurements, but the registry record does not give the calculation method, the exact concentration-time interval used for each reported summary, or details of how values across visits contributed to the final measure. The reported endpoint therefore supports a descriptive comparison of the posted means, not conclusions about clinical effects.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted mean AUC is 2657.0 for CoQ10 once daily, with a 95% confidence interval from 2224.0 to 3091.0. For CoQ10 twice a day, the posted mean is 3459.0, with a 95% confidence interval from 2807.0 to 4111.0. These summaries describe the observed endpoint in the two randomized groups. The twice-daily group has the higher reported mean, but the registry record does not report a between-group estimate, confidence interval for the difference, or hypothesis test.
A confidence interval communicates uncertainty around an estimated group mean under the statistical assumptions used to construct it. It is not a range containing a stated proportion of individual participants’ measurements, and it does not by itself establish that one regimen differs from the other. The registry describes the intervals as 95% confidence intervals, but does not report the construction method or supporting distributional diagnostics. The interval estimates should therefore be read as the record presents them, without assuming unreported modeling details.
The group sizes for this endpoint are 12 in each arm. A relatively small study can yield imprecise estimates, and confidence intervals show some of that uncertainty. These intervals are for each group’s mean, not for the difference between means. A direct comparison would require an estimate of the between-group contrast and its uncertainty, or a suitable test result. Neither is reported in the registry record. It would be inappropriate to infer a statistically significant or non-significant contrast from the group summaries alone.
The registry states that the study was exploratory and that descriptive statistics and confidence intervals would be provided. That framing matters: the reported outcome helps describe pharmacokinetic exposure under the two schedules, while the record does not establish a confirmatory statistical conclusion. There are no posted analysis records, and no p-value, adjusted estimate, or model-based comparison is reported. Accordingly, the numerical difference in the displayed group means is a descriptive feature, not a reported estimate of a treatment effect with quantified uncertainty.
The interpretation is also limited by the endpoint description. It gives one unit in the endpoint summary and another in the outcome description, and it includes “≥5” without explaining the role of that criterion. The registry does not specify how the AUC was calculated or how repeated measurements were combined. These reporting details make it difficult to map the posted means precisely to a particular concentration-time calculation or threshold. They do not change the fact that the listed means and confidence intervals are the registry’s reported summaries, but they constrain further interpretation.
The study objective refers to reaching a plasma concentration that might assure an antioxidant effect with regular use. The posted result measures pharmacokinetic exposure; it does not report an antioxidant outcome or a clinical endpoint. The results therefore describe exposure summaries in the study groups, rather than demonstrating that a target was achieved, that an antioxidant effect occurred, or that either schedule changes health outcomes. The registry record also does not report follow-up beyond the stated outcome timeframe or evidence about use outside the study setting.
9. Statistical Methods Explained
In general, a continuous endpoint is measured on a numerical scale, and a group mean describes its average value. A mean is informative about the center of a group’s measurements, but it does not show their full distribution. Participants can have measurements above or below the mean, and the mean alone does not reveal how variable individual values were. For this study, the primary outcome is a continuous pharmacokinetic measure, and the posted summaries use means rather than medians or event counts.
What the confidence intervals express
In general, a confidence interval pairs an estimate with a range of values that reflects sampling uncertainty under a specified method and its assumptions. A 95% confidence interval is not a statement that 95% of participants’ values lie within its limits. It also is not, by itself, a probability statement that the particular interval contains the fixed true value. Rather, the confidence level describes the long-run performance of the interval procedure under repeated sampling, when its assumptions hold.
The registry reports a 95% confidence interval for each group mean. It does not report the interval-construction method, standard errors, standard deviations, or individual-level measurements. Consequently, the displayed intervals can be described as uncertainty summaries for the reported means, but the record does not allow a reader to independently verify their calculation or examine the within-group distribution. The intervals should not be mistaken for confidence intervals around the difference between regimens.
Why a direct contrast is different
A comparison of two regimens is usually expressed as a between-group contrast, such as a difference in means, together with an uncertainty interval or test. That contrast directly addresses how far apart the group estimates are and how uncertain that separation is. Separate group means and their separate confidence intervals do not supply the contrast interval. In general, the uncertainty of a contrast depends on the variability and sample sizes in both groups and on the chosen analysis. No between-group estimate or test is reported in the registry record, so no inferential claim about the contrast can be attributed to the posted analysis.
The registry’s description explicitly calls for descriptive statistics and 95% confidence intervals because the study is exploratory. Descriptive reporting is useful for characterizing the observed data and can inform later research planning. It should not be recast as a confirmatory test when the record does not report one. The posted arm means are summaries of these participants, and their precision is represented by their reported intervals, subject to the unreported calculation details.
What the design contributes
Random allocation, in general, is intended to make treatment groups comparable with respect to both measured and unmeasured characteristics at the point of assignment. It does not guarantee balance in a small study, and it does not remove uncertainty from the estimates. The registry identifies randomized allocation, a parallel model, and no masking. It does not report how the random sequence was generated, how assignments were concealed, or whether stratification was used. No claims about those procedures can be made from the record.
Open-label design means that masking is absent. In general, knowledge of assigned regimen can affect behavior, reporting, or assessment, depending on the outcome and study procedures. A pharmacokinetic measure has a numerical laboratory component, but the registry does not describe assay blinding, sample handling, or other measures that may affect assessment. Therefore, it is not possible to assess those safeguards from the record. The dosing schedules also differ in frequency, which is the intended contrast described by the study arms.
Distribution and over-dispersion
In general, over-dispersion means that observed variability exceeds what a model assumes. It is especially relevant when an analysis relies on a probability model whose variance assumptions are too restrictive: uncertainty estimates can then be too small, and test results can be misleading. A continuous AUC outcome may have a distribution that is asymmetric or contains unusually high values, but the registry record gives no individual measurements, variability estimates, diagnostic plots, or model specification. There is no basis in the record for saying whether over-dispersion or another distributional issue occurred in this study.
For continuous outcomes, analysts may consider the scale of measurement, the shape of the distribution, and whether a transformation or robust method is appropriate. Those are general statistical considerations, not reported methods for this trial. The registry describes means and confidence intervals but does not report whether assumptions were checked, whether any transformation was used, or how outlying or incomplete observations were handled. Those unknowns matter because the reliability of an interval can depend on the analysis method and data structure.
Exploratory findings and planning
Exploratory studies can help describe exposure patterns and identify questions for later evaluation, while their estimates can remain uncertain. A sample-size calculation for a future study may use an observed effect as an input, but such planning values are not observed power and do not establish that the current study was adequately powered for a confirmatory objective. The registry record does not report a sample-size justification or a formal power calculation for this study. Any planning illustration associated with the reported summaries should be understood as planning rather than as a description of the trial’s design rationale or evidence of the probability that it detected an effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, but no secondary outcomes are posted and no analysis records are listed. It identifies one primary outcome concerning AUC. The record does not report a multiplicity strategy, such as a hierarchy of hypotheses or an adjustment for testing multiple endpoints. Because no inferential tests are reported, there is also no stated family of p-values or adjustment to interpret. This absence should not be filled by assuming that testing was performed or that multiplicity was addressed in a particular way.
The record does not describe missing-data methods, the number of participants with missing endpoint measurements, or how incomplete concentration-time profiles were handled. It also does not state whether the primary summaries include all randomized participants, only participants with evaluable data, or another analysis population. The group summaries list 12 participants per arm, but that alone does not establish the analysis-population definition or prove that every participant contributed all measurements.
In general, missing measurements can affect a continuous summary if the people with observed data differ from those without data. The extent and direction of any such effect depend on why values are missing and on the analysis method. Without details on missingness and handling, no judgment about its impact is possible. The registry record also does not report protocol deviations, exclusions from the analysis, or sensitivity analyses. These gaps limit assessment of how complete and robust the endpoint summaries are.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| CoQ10 Once Daily After Randomization | 0 | 12 | 0.0% |
| CoQ10 Twice a Day After Randomization | 0 | 12 | 0.0% |
| CoQ10 Once Daily Before Randomization | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CoQ10 Once Daily After Randomization | 0 of 12 |
| CoQ10 Twice a Day After Randomization | 0 of 12 |
| CoQ10 Once Daily Before Randomization | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CoQ10 Once Daily After Randomization | 0 of 12 |
| CoQ10 Twice a Day After Randomization | 3 of 12 |
| CoQ10 Once Daily Before Randomization | 0 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CoQ10 Once Daily After Randomization | CoQ10 Twice a Day After Randomization | CoQ10 Once Daily Before Randomization |
|---|---|---|---|---|
| DIZZINESS | Ear and labyrinth disorders | 0 of 12 | 1 of 12 | 0 of 24 |
| RESPIRATORY VIROSIS | Respiratory, thoracic and mediastinal disorders | 0 of 12 | 1 of 12 | 0 of 24 |
| PULTACEOUS ANGINA | Cardiac disorders | 0 of 12 | 1 of 12 | 0 of 24 |
For the post-randomization safety groups, the registry reports no serious adverse events among the 12 participants at risk in either the once-daily or twice-a-day group. It reports no deaths in either group. For other adverse events, the once-daily group has 0 among 12 at risk, while the twice-a-day group has 3 among 12 at risk. The registry also lists a pre-randomization once-daily group with 0 other events and 0 serious events among 24 at risk, with no deaths.
These are event counts within the registry’s stated groups, not a formal comparison of safety between regimens. The record does not report event descriptions in the serious-event terms list, which is empty, or details about timing, severity beyond the serious/non-serious categories, relatedness, or duration. A zero serious-event count in this study means none were reported in the listed group during the recorded period; it does not demonstrate that serious events cannot occur. The small group sizes and the registry’s limited safety details constrain interpretation.
12. What the Result Does, and Does Not, Mean
The result describes mean AUC values for two COQUN dosing schedules in healthy adults, alongside a 95% confidence interval for each group mean. The twice-a-day group has a higher posted mean than the once-daily group. This is a descriptive comparison of the reported summaries. The registry record does not provide a direct estimate of the difference between regimens or a statistical test, so the result does not establish whether the observed separation is compatible with random variation under a specified inferential model.
The endpoint is pharmacokinetic, not a clinical outcome. It can describe concentration exposure over time, but it does not by itself establish an antioxidant effect, symptom improvement, prevention of illness, or any other health benefit. The study objective mentions a concentration that might assure an antioxidant effect with regular use; the posted primary result does not report an antioxidant measure or show that the stated threshold was achieved. The role of “≥5” is not explained in the registry record.
The study also cannot, from the information reported, establish that one schedule is preferable for use beyond the trial setting. It enrolled healthy volunteers, and the registry does not describe results in people with a specific condition. It does not report a detailed assessment of adherence, longer-term outcomes, or a formal safety comparison. The absence of serious events in the listed groups is a description of the reported observations, not evidence that a regimen is risk-free.
Interpretation should remain within the study’s exploratory context. The record does not report a sample-size justification, analysis plan, missing-data approach, or between-group inference. The endpoint unit is expressed differently in the outcome title and its description. Together, these reporting limits mean the posted summaries are most useful as a description of the observed pharmacokinetic values and their stated uncertainty, rather than as a definitive estimate of a clinical effect or a basis for a treatment recommendation.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how an exploratory pharmacokinetic study can report group means and confidence intervals without posting a formal between-group analysis. A mean gives a concise description of each group, while a confidence interval communicates uncertainty around that mean. Keeping those summaries distinct from a contrast estimate helps prevent a common interpretive error: treating separate arm results as though they were a test of the difference between arms.
The randomized parallel design establishes the intended basis for comparing two dosing schedules, and the equal group sizes make the two descriptive summaries straightforward to read side by side. Still, randomization does not replace reporting the analysis used to compare outcomes. A direct contrast, its uncertainty, and the analysis population would be needed to evaluate the comparative question inferentially. Those details are not reported in the registry record.
The study also illustrates why precise endpoint definitions matter. AUC is a recognized type of exposure summary, but the record contains different unit expressions and does not clarify the role of the listed threshold. Without a clearly specified scale and calculation, readers cannot fully evaluate what the reported numbers represent or compare them confidently with another study.
Finally, an exploratory pharmacokinetic result and a clinical effect answer different questions. The study’s stated aim relates exposure to a possible antioxidant effect, but the posted primary measure is AUC. Recognizing that distinction keeps conclusions aligned with what was measured and reported. The result can describe exposure in the study groups while leaving clinical effectiveness and broader safety questions unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the information reported for this trial. The registry describes the study as randomized, but does not report sequence generation, allocation concealment, or other details needed to assess the implementation of randomization. It records no masking. The study is therefore open-label according to the record, while the record does not describe whether laboratory assessment or data processing was blinded.
The primary endpoint’s units are not consistent across the record: the endpoint unit is microg/l*days, while the outcome description gives microg/ml x h. The registry does not explain whether these expressions refer to different representations or identify which one should govern interpretation. The “≥5” notation is also not explained. The AUC calculation, handling of measurements across visits, and precise aggregation period are not reported.
The posted summaries include means and 95% confidence intervals, but no standard deviations, individual data, model description, or direct between-group estimate. There are no analysis records, and the registry does not report a statistical analysis plan, sample-size justification, or a formal comparison. The record also does not explain the analysis population, missing data, exclusions, protocol deviations, or sensitivity analyses. These gaps prevent assessment of robustness and make it inappropriate to infer a confirmatory result from the arm summaries alone.
The enrollment was 24, with 12 participants in each posted primary outcome group. The study population is described as healthy male and female volunteers, and the registry does not provide further demographic or eligibility details. Safety reporting is limited to event counts and does not include the nature or relatedness of the other adverse events. These constraints limit how broadly the results can be interpreted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bioavailability Study of COQUN ORAL FORMULATION — NCT03819491.
- Registry record last updated 2019-09-06; status last verified 2019-07.
- Results first posted 2019-09-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed, randomized, open-label, parallel-group Phase 1 bioavailability study of COQUN oral formulation (CoQ10) in healthy adults. Enrollment was 24. One group received 100 mg once daily and the other received 100 mg twice a day. The sponsor is VISUfarma SpA; the recorded start date is 2018-06-22, and primary completion is dated 2018-08-29.
The primary endpoint is mean AUC from day-7 to day 28, reported with 95% confidence intervals. The once-daily group mean is 2657.0, with an interval from 2224.0 to 3091.0; the twice-a-day group mean is 3459.0, with an interval from 2807.0 to 4111.0. The registry does not report a direct between-group analysis. It lists no posted secondary outcomes or analysis records. Serious adverse events and deaths are reported as 0 in both post-randomization groups; other events are reported as 0 for once daily and 3 for twice a day.