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 Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions (NCT06855576), a randomized phase 1 study. The primary outcome is Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06855576 |
| Phase | Phase 1 |
| Condition | Fever, Pain |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 54 |
| Arms in the primary outcome | 2 |
| Lead sponsor | HALEON |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy adult subjects under fasting conditions. The registry record describes a Phase I study with an enrollment of 54. Its primary pharmacokinetic analysis population was narrower: the PKAS included people in the PK population who completed at least two periods with one test formulation and had no major protocol deviations concerning pharmacokinetics. The full definition of the PK population is not reported in the registry record.
Intervention
The test product was a paracetamol orodispersible tablet, described in the official title as 500 mg. Each treatment was given as a single oral dose. The study was conducted under fasting conditions.
Comparator
The two reference products were Alvedon 500 mg film-coated tablet, identified as the European marketed reference, and Panadol 500 mg film-coated tablet, identified as the Australian marketed reference. The posted primary endpoint is specifically the comparison of the test product with Alvedon. A primary endpoint comparison with Panadol is not reported in the registry record.
Primary question
The primary question was whether the test product’s maximum observed plasma concentration, Cmax, was comparable with that of Alvedon. The reported sponsor analysis gives a ratio of geometric least squares means of 82.22, with a 90% confidence interval from 76.12 to 88.8. The registry record does not state the acceptance bounds used to judge bioequivalence, so the interval alone does not establish whether a prespecified bioequivalence criterion was met.
3. Trial Design
This was a Phase I, randomized, open-label, single-center, single oral dose, three-treatment, three-period, three-sequence crossover study. The treatments were paracetamol ODT, Alvedon film-coated tablet, and Panadol film-coated tablet. Enrollment was 54, and the registry status is completed. The listed study dates are 2025-03-05 for study start and 2025-04-17 for primary completion.
In a crossover design, participants receive different treatments in different periods, rather than being assigned to remain in a single treatment group throughout. The registry describes participants as randomly assigned across sequences, with the order of test and reference products varying. Thus, treatment comparisons can be made using observations from participants who received the different products. In general, this design can account for stable differences between participants, because each person can contribute observations under more than one treatment. That general advantage does not establish how the analysis was implemented in this study.
The study was open label, so masking was not used. A washout interval, sequence-generation details, and any procedures to reduce or assess period or carryover effects are not reported in the registry record. The statistical model used for the reported comparison is also not reported there. The trial’s stated aim was to assess bioequivalence of the new ODT formulation against both marketed film-coated references. However, the posted primary endpoint is the ODT-versus-Alvedon Cmax comparison; a corresponding primary Cmax result against Panadol is not reported in the registry record.
The registry lists fever and pain as conditions and identifies Haleon as sponsor. The study’s purpose was a pharmacokinetic comparison in healthy adults, not an assessment of symptom relief in patients. The posted results therefore address the measured concentration endpoint in the study population and setting, not clinical outcomes in people seeking treatment for fever or pain.
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 assignment: A total of 54 participants were enrolled and randomized to treatment groups. A total of 52 randomized participants subsequently completed the study.
Treatment Period 1 (1 Day)
| Stage | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| STARTED | 18 | 18 | 18 |
| COMPLETED | 18 | 18 | 18 |
| NOT COMPLETED | 0 | 0 | 0 |
Washout Period 1 (3 Days)
| Stage | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| STARTED | 18 | 18 | 18 |
| COMPLETED | 18 | 17 | 18 |
| NOT COMPLETED | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 0 |
Treatment Period 2 (1 Day)
| Stage | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| STARTED | 18 | 17 | 18 |
| COMPLETED | 17 | 17 | 18 |
| NOT COMPLETED | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 |
Washout Period 2 (3 Days)
| Stage | Test Product/ Reference Product 2/ Reference Product 1 | Reference Product 1/ Test Product/ Reference Product 2 | Reference Product 2/ Reference Product 1/ Test Product |
|---|---|---|---|
| STARTED | 17 | 17 | 18 |
| COMPLETED | 17 | 17 | 18 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The PKAS (pharmacokinetics analysis set) was defined as all participants in the PK population who completed at least two periods with one test formulation and who had no major protocol deviations concerning pharmacokinetics. The PK population was defined as all randomised participants who had at least one measurable PK parameter. Only those participants with data available at the specified timepoint were analyzed.
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.
Population: The Safety Population included all randomised participants who received at least one dose of study medication.
| Characteristic | Unit | Overall Study Participants |
|---|---|---|
| Participants analysed | 54 | |
| Age, Continuous | years | 37 (SD 9.8) |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 27 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1), measured over Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | micrograms per milliliter(µg/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was maximum observed post-dose plasma concentration of paracetamol, or Cmax, for the test ODT versus the Alvedon reference. It is expressed in micrograms per milliliter (µg/mL). The registry defines Cmax as the highest observed post-dose plasma concentration. Blood samples were collected within one hour before dosing, at scheduled times from 5 through 180 minutes, and at 4 through 24 hours after dosing in each treatment period. Pharmacokinetic parameters were determined by non-compartmental analysis.
Cmax is used in pharmacokinetic comparisons because it describes the highest measured concentration after a dose. For bioequivalence assessment, comparing this measure can help characterize whether the concentration profile’s peak is similar between formulations. It is not, by itself, a measure of symptom relief, duration of effect, or safety in a broader patient population.
The posted primary endpoint summarizes each treatment using a geometric mean and geometric coefficient of variation. The registry reports a sponsor analysis as a ratio of geometric least squares means, with a 90% confidence interval. The endpoint description does not give a separate time-to-peak result, and such a result is not reported in the registry record. The sampling schedule supports observation of concentrations over time, but the registry result addressed is the Cmax comparison, not the full concentration-time profile.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The sponsor’s posted primary comparison is the paracetamol ODT against Alvedon for Cmax. The geometric mean was 6.27 for the test product, based on 53 participants, and 7.71 for Reference Product 1, based on 51 participants. The respective geometric coefficients of variation were 36.8 and 53.6. The sponsor-reported ratio of geometric least squares means was 82.22, with a 90% confidence interval from 76.12 to 88.8.
The ratio is the principal comparative estimate. A ratio expresses the test treatment’s estimated geometric least squares mean relative to the reference treatment’s estimate, under the sponsor’s analysis. The interval describes uncertainty around that estimate according to the reported analysis. It is not a range containing every individual participant’s concentration, nor does it describe the variation between individuals. The arm-level geometric coefficients of variation describe variability in the treatment observations, while the confidence interval describes precision for the estimated comparison.
The interval’s endpoints are relevant to a bioequivalence conclusion only alongside the prespecified acceptance bounds. Those bounds are not reported in the registry record. As a result, the numerical estimate and its interval can be described, but a conclusion that the criterion was met or not met cannot be established from the posted information alone. The registry reports no p-value for this equivalence analysis, and a conventional test against equality would not substitute for the specified equivalence assessment.
The primary result is limited to ODT versus Alvedon for Cmax. Although the stated aim also includes Panadol, the matching primary comparison against Panadol is not reported in the registry record. The listed secondary outcomes include AUC and other pharmacokinetic measures, but their presence does not supply the missing primary comparison. Values missing or not estimable for a two-arm comparison are not available for some other endpoints.
These findings describe the posted pharmacokinetic analysis in healthy adults under fasting conditions. They do not establish how concentrations compare in other populations or conditions, and they do not directly address clinical effectiveness. The enrollment of 54 is the study enrollment, not the number contributing to each reported arm-level summary: the posted Cmax summaries use 53 for the test product and 51 for Alvedon. Reasons for the differing analysis counts are not reported in the registry record.
9. Statistical Methods Explained
The reported primary analysis uses a ratio of geometric least squares means and a 90% confidence interval. The registry identifies the arm summaries as geometric means with geometric coefficients of variation, but does not report the model or estimation method used to obtain the least squares means. The following statistical explanations are general; they do not identify an unreported feature of this study’s analysis.
Why use a ratio of geometric means?
Pharmacokinetic concentrations are often analyzed on a logarithmic scale because concentration data can be positively skewed and treatment differences are commonly interpreted proportionally. On the original scale, the ratio of geometric means expresses the estimated concentration for the test treatment relative to the reference. A ratio close to 100 on the registry’s reporting scale corresponds to similar estimated geometric means. The estimate of 82.22 is the reported ratio; it should not be converted into a difference or another measure without the underlying analysis details.
Least squares means are model-based estimates. In general, such estimates may account for factors included in a statistical model, whereas a simple geometric mean summarizes observations within a treatment group. The registry does not state which factors were included, how the crossover structure was represented, or how the estimates were obtained. The reported ratio should therefore be interpreted as the sponsor’s analysis result, not reconstructed from the two arm-level geometric means.
What does the confidence interval communicate?
In general, a confidence interval conveys the uncertainty of an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval for the same estimand and method. The interval from 76.12 to 88.8 is reported at the 90% level. It concerns the estimated treatment ratio, not the spread of individual measurements. Its interpretation depends on the analysis model and assumptions, which are not fully described in the registry record.
For an equivalence question, the interval is assessed against prespecified acceptable limits. The criterion is not simply whether the interval includes a ratio of 100. The registry record does not report the acceptance limits or the detailed decision rule. Therefore, the interval can be reported as evidence about the estimated ratio and its precision, but the equivalence decision cannot be independently checked from the registry information described.
How does crossover structure matter?
In general, crossover analyses account for the fact that measurements from the same participant across periods are related. A suitable analysis can distinguish treatment effects from participant-level variation and may also need to consider period and sequence. This matters because treating all observations as if they came from unrelated participants can misrepresent uncertainty. The registry confirms a randomized, three-treatment, three-period, three-sequence crossover design, but does not report the primary analysis model, its covariance assumptions, or how period, sequence, and possible carryover were handled. Those details cannot be inferred from the design label alone.
The arm-level sample counts differ: 53 for the test product and 51 for Alvedon. In a crossover study, treatment-specific counts need not be identical if not all participants contribute usable observations to every treatment analysis. The registry’s PKAS description requires completion of at least two periods with one test formulation and no major pharmacokinetic protocol deviations, but the full PK population definition and reasons for the treatment-specific counts are not reported in the registry record.
What do the variability summaries mean?
The geometric coefficient of variation is a measure of relative variability on the scale used for the geometric summary. In general, it helps describe how dispersed observations are relative to their geometric mean. It is distinct from the confidence interval for the treatment ratio. The posted values are 36.8 for the test product and 53.6 for Alvedon. These values describe variability within the respective treatment summaries; they do not by themselves establish whether the treatment comparison is precise or satisfies an equivalence criterion.
The registry lists 18 outcome measures and 6 analyses, with 12 secondary outcomes posted. Those counts do not reveal whether adjustments for multiple testing were applied. The multiplicity approach, missing-data procedures, and any interim analyses are not reported in the registry record. They should not be assumed from the number or type of endpoints.
Planning illustrations based on the observed effect are not observed power. In general, sample-size calculations describe assumptions under which a future or planned study might achieve a target operating characteristic; they do not measure the probability that the completed study’s result is correct. The registry’s stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. No planning illustration can replace the observed estimate and its interval, and its assumptions do not document the original trial’s design justification. The trial’s own sample-size justification is not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| not stated | Ratio of Geometric Least Square Mean 82.22 | 76.12 to 88.8 | not reported |
The registry reports the sponsor’s equivalence analysis as a ratio of geometric least squares means of 82.22, with a 90% confidence interval from 76.12 to 88.8. It also reports the treatment-specific geometric means and geometric coefficients of variation for the test product and Alvedon. The analysis method is not specified in the registry record, so the model-based estimate cannot be reproduced from the arm summaries alone.
A separate recalculated estimate is not reported in the registry record. The record does not flag a discrepancy between the sponsor analysis and a recalculation. The sponsor’s reported analysis is therefore the available comparative result; the summary statistics are descriptive context, not an independent replacement for that analysis. In any event, the equivalence acceptance bounds are not reported, limiting independent assessment of the decision criterion.
The available sponsor comparison concerns Cmax for ODT versus Alvedon. A sponsor-reported primary comparison of ODT with Panadol is not reported in the registry record. The absence of that comparison should not be interpreted as evidence either for or against similarity to Panadol.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 18 outcome measures, 6 analyses, and 12 posted secondary outcomes. It identifies the primary outcome as Cmax for the test ODT versus Alvedon. The multiplicity strategy for the several outcomes and analyses is not reported in the registry record. It is therefore not possible to determine whether the analyses were treated as confirmatory or exploratory, whether a testing hierarchy was used, or whether any adjustment was made for multiple comparisons.
The primary analysis population is described as the PKAS. This set includes participants in the PK population who completed at least two periods with one test formulation and had no major protocol deviations concerning pharmacokinetics. The full definition of the PK population is incomplete in the registry record. The primary arm summaries have counts of 53 for the test product and 51 for Alvedon, while the safety groups list 53 at risk for each treatment. These counts refer to different posted summaries and should not be treated as interchangeable.
Missing-data rules, handling of participants with incomplete periods, and the reasons observations were not included are not reported in the registry record. The registry also does not report whether any data were imputed or how protocol deviations were adjudicated beyond the brief PKAS definition. Interim analyses and the statistical plan for missing outcomes are not reported either.
These omissions matter because the analysis population, missingness, and multiplicity can affect the interpretation of uncertainty and the strength of conclusions. The posted result remains interpretable as the sponsor-reported estimate for the defined primary endpoint, but the record does not provide enough detail to reconstruct all analysis decisions or assess their consequences.
12. 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 |
|---|---|---|---|
| Test Product | 0 | 53 | 0.0% |
| Reference Product 1 | 0 | 53 | 0.0% |
| Reference Product 2 | 0 | 53 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test Product | 0 of 53 |
| Reference Product 1 | 0 of 53 |
| Reference Product 2 | 0 of 53 |
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 |
|---|---|
| Test Product | 12 of 53 |
| Reference Product 1 | 16 of 53 |
| Reference Product 2 | 9 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Test Product | Reference Product 1 | Reference Product 2 |
|---|---|---|---|---|
| Presyncope | Nervous system disorders | 1 of 53 | 3 of 53 | 1 of 53 |
| Headache | Nervous system disorders | 0 of 53 | 3 of 53 | 1 of 53 |
| Nausea | Gastrointestinal disorders | 2 of 53 | 1 of 53 | 0 of 53 |
| Blood pressure diastolic increased | Investigations | 1 of 53 | 1 of 53 | 1 of 53 |
| Urinary tract infection | Infections and infestations | 1 of 53 | 0 of 53 | 1 of 53 |
| Blood thyroid stimulating hormone increased | Investigations | 1 of 53 | 0 of 53 | 1 of 53 |
| Abdominal distension | Gastrointestinal disorders | 1 of 53 | 0 of 53 | 0 of 53 |
| Abdominal pain upper | Gastrointestinal disorders | 1 of 53 | 0 of 53 | 0 of 53 |
| Blood cholesterol increased | Investigations | 1 of 53 | 0 of 53 | 0 of 53 |
| Blood pressure increased | Investigations | 1 of 53 | 0 of 53 | 0 of 53 |
The posted safety groups list 53 participants at risk for each treatment. Serious adverse events affected 0 in the Test Product group, 0 in the Reference Product 1 group, and 0 in the Reference Product 2 group. Deaths were 0 in all three groups. These are the registry’s recorded counts for the treatment groups; they do not establish that an event could not occur in a larger or different population.
The registry also lists other adverse events affecting 12 in the Test Product group, 16 in Reference Product 1, and 9 in Reference Product 2. These counts are distinct from the serious adverse event counts. The registry record does not provide further detail about event types, severity, relatedness, or participant overlap between treatment groups. Because this was a crossover study, the treatment groups should not automatically be read as independent sets of participants. The counts describe the posted safety results and do not support a simple causal comparison without the relevant design and analysis details.
The safety figures are from a study in healthy adults, with a limited enrollment and single-dose treatment periods. They characterize events recorded in this trial and do not provide a comprehensive safety assessment for other settings or durations of use.
13. What the Result Does, and Does Not, Mean
The posted result estimates the relative Cmax for paracetamol ODT compared with Alvedon in a randomized crossover study of healthy adults under fasting conditions. The sponsor reported a ratio of geometric least squares means of 82.22 and a 90% confidence interval from 76.12 to 88.8. The treatment summaries also report geometric means of 6.27 for the test product and 7.71 for Alvedon, with geometric coefficients of variation of 36.8 and 53.6, respectively.
These statistics describe a pharmacokinetic endpoint: the maximum observed plasma concentration after dosing. They do not directly measure symptom relief, duration of benefit, or clinical outcomes. Nor do they establish how the products compare in populations other than the healthy adult subjects studied, under conditions other than fasting, or with dosing beyond the single oral dose described.
The study’s stated objective includes comparison with both Alvedon and Panadol, but the posted primary result is for Alvedon. The record does not report a primary Cmax comparison with Panadol. The registry also does not state the bioequivalence acceptance limits. Accordingly, the reported point estimate and interval can be interpreted as the sponsor’s comparative estimate and its stated uncertainty, but they do not alone permit confirmation that a specified bioequivalence criterion was met.
Zero serious adverse events and zero deaths were recorded in the three safety groups. This is a description of the observed safety record, not proof of absence of risk. Overall, the posted information answers a focused pharmacokinetic comparison for a specific endpoint and setting. It does not answer broader questions about clinical outcomes, other patient groups, or unreported comparisons.
14. Why This Trial Matters Statistically
This trial illustrates why a bioequivalence result is more than a comparison of two treatment averages. The primary estimate is a ratio of geometric least squares means, accompanied by a confidence interval. The ratio describes the relative treatment estimate, while the interval communicates uncertainty. Both need to be considered alongside the acceptance limits specified for the equivalence question. Those limits are not reported in the registry record, so the estimate cannot be converted into a verified pass-or-fail conclusion from the posted information alone.
The crossover design is also statistically important. Participants received treatments across periods and sequences, so observations are related within participants. An appropriate analysis should reflect that structure. The registry reports the design but not the model, leaving readers unable to examine how treatment, period, and participant-level variation were handled. This is a useful distinction between knowing the design and knowing the analysis.
The record also demonstrates why analysis populations and endpoint availability matter. Enrollment was 54, while the primary treatment summaries use 53 and 51 participants. The PKAS definition gives some eligibility details, but the complete population definition and reasons for the different counts are not reported. A headline enrollment figure does not by itself identify who contributed to each estimate.
Finally, the study’s objective names two reference products, but the posted primary comparison concerns Alvedon. Explicitly separating the stated objective from the available endpoint result prevents a result for one reference from being generalized to another. The statistical lesson is to interpret each estimate within its stated treatment contrast, population, and endpoint.
15. 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.
The registry record does not report the equivalence acceptance bounds. Without those prespecified limits, the reported ratio and 90% confidence interval cannot establish whether the bioequivalence decision criterion was met. The statistical model and detailed analysis method are also not reported, so the sponsor’s estimate cannot be independently reconstructed from the posted arm summaries.
The study’s stated aim includes comparison against Alvedon and Panadol, but the posted primary Cmax comparison is only against Alvedon. A corresponding primary result against Panadol is not reported in the registry record. Some other endpoints have values missing or not estimable for a two-arm comparison. The set of secondary outcomes is listed, but no broader conclusion about all pharmacokinetic comparisons can be drawn from the primary result.
The enrollment was 54, while Cmax summaries include 53 for the test product and 51 for Alvedon. The record does not explain the differing counts or provide a full account of missing observations, exclusions, or protocol deviations. The PKAS description is available, but the full PK population definition is not reported. The approach to multiplicity and any interim analyses are not reported either.
Further design and conduct details, including washout interval, sequence-generation procedure, and handling of period or carryover effects, are not reported in the registry record. The study was open label and conducted in healthy adults under fasting conditions with single oral doses. Its results therefore have a defined population and setting and should not be taken as estimates for other circumstances.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions — NCT06855576.
- Registry record last updated 2026-07-01; status last verified 2026-06.
- Results first posted 2026-07-01.
- 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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19. Record Summary
NCT06855576 is a completed Phase I randomized, open-label, single-center crossover study of paracetamol ODT against Alvedon and Panadol film-coated tablets in healthy adults under fasting conditions. Enrollment was 54. The primary endpoint was Cmax for ODT versus Alvedon.
The sponsor-reported ratio of geometric least squares means was 82.22, with a 90% confidence interval from 76.12 to 88.8. The registry does not report the equivalence acceptance limits, so the criterion cannot be independently assessed from the posted result. The primary comparison against Panadol, the analysis model, multiplicity approach, and several details about missing data and analysis populations are not reported in the registry record.
Zero serious adverse events and zero deaths were listed in each treatment safety group. These figures describe the observed trial record and do not establish safety beyond this study’s population and single-dose setting.