A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions (NCT01235195), a randomized phase 1 study. The primary outcome is Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)].

2. Clinical Question

3. Trial Design

This was a Phase 1, randomized, open-label, single-dose, two-treatment, two-period crossover bioequivalence study under fasted conditions. Participants received the two sertraline formulations in a crossover design, so treatment comparisons are made within a study structured around both formulations rather than as a simple comparison of unrelated groups. The registry records 30 participants enrolled and 30 observations for each treatment in the primary outcome.

Random allocation is reported, but the registry record does not report the treatment sequences, the interval between periods, or how the sequence assignment was implemented. It also does not report whether a washout period was used or its duration. Those details matter in crossover studies because the interpretation depends on separating the effect of the treatment in a period from any influence of the preceding treatment or period. They cannot be inferred from the design label alone.

The study was completed. Its recorded start was 2010-11 and its primary completion was 2010-12. The listed population was healthy participants. The primary pharmacokinetic outcome was area under the concentration-time curve from time zero to 72 hours, measured from predose and scheduled postdose samples through 72 hours. The registry describes the analysis population as all treated participants with at least one sertraline concentration evaluated for pharmacokinetics.

The registry record does not report the original sample-size justification, the planned statistical model, the handling of period or sequence effects, or the treatment of missing concentration measurements. It also does not report the protocol’s analysis populations beyond the primary outcome description. These omissions limit how fully the posted comparison can be reconstructed from the registry alone.

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.

First Intervention

Washout Period of At Least 8 Days

Second Intervention

Analysis population for the primary outcome, as defined in the registry: All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.

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.

6. Primary Endpoint

The registry lists the primary outcome as Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)], measured over Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.

The primary endpoint was area under the plasma concentration-time curve from time zero to 72 hours, expressed in nanogram hour per milliliter (ng*h/mL). The area under a concentration-time curve represents exposure over a specified interval: it takes account of measured concentrations across time rather than relying on a concentration at a single sampling point. The registry defines the measure as the area from predose to 72 hours and lists samples at predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.

For a formulation comparison, an exposure measure can help describe whether the amount of drug reaching the measured circulation over the observation interval differs between dosage forms. It is a pharmacokinetic endpoint, not a direct measure of a clinical outcome. The registry reports means and standard deviations by formulation, alongside the sponsor’s ratio of adjusted means. The endpoint’s clinical or regulatory interpretation depends on the analysis plan and decision criteria, which are not reported in the registry record. In particular, the posted endpoint values alone do not specify what range of differences would meet a formal bioequivalence criterion.

7. Results Posted in the Registry

• Sertraline 50 mg Film-Coated Tablet: mean 442.10 versus 419.90 on control; difference 22.20 (95% CI -58.04 to 102.44), standardized effect d = 0.14; z-test p = 0.588.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Sertraline 50 mg Film-Coated Tablet: mean 493.80 versus 471.40 on control; difference 22.40 (95% CI -77.56 to 122.36), standardized effect d = 0.11; z-test p = 0.661.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sertraline 50 mg Film-Coated Tablet and the control. The interval gives the range of effects that remain compatible with the data.

Plasma Decay Half-Life (t1/2)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Sertraline 50 mg Film-Coated Tablet: mean 25.40 versus 25.45 on control; difference -0.05 (95% CI -1.90 to 1.80), standardized effect d = -0.01; z-test p = 0.958.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sertraline 50 mg Film-Coated Tablet and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover additional pharmacokinetic measures: area under the curve from time zero to extrapolated infinite time and plasma decay half-life. Across the available secondary summaries, the reported mean differences are small relative to the scales of the measures, and their recalculated confidence intervals include zero. The registry also names time to maximum observed plasma concentration and residual area under the concentration-time curve among secondary outcomes, but their numerical results are not reported in the registry record.

The available secondary pattern is broadly consistent with the primary result in the limited sense that the posted recalculations do not identify a clearly separated treatment difference. That observation should not be treated as independent confirmation of the primary finding. The endpoints assess related aspects of pharmacokinetics, and their estimates may be correlated because they arise from the same study and concentration measurements. A collection of uncertain estimates does not become conclusive simply because the directions appear similar.

The registry does not report a multiplicity adjustment, a hierarchy for testing the secondary outcomes, or a prespecified strategy for interpreting them. If several outcomes are examined, the chance of at least one apparently unusual result can increase unless the analysis accounts for that multiplicity. Unadjusted secondary results are therefore exploratory in interpretation and generally carry less weight than a clearly prespecified primary analysis. This caution is especially important where the analysis methods and missing-data handling are not reported.

Secondary outcomes can help describe the shape and duration of exposure, but they do not replace the primary endpoint or resolve the missing details about the formal bioequivalence criteria. The unreported secondary results also mean that a complete assessment of the full set of named pharmacokinetic outcomes is not possible from the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time to Reach Maximum Observed Plasma Concentration (Tmax)
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
• Residual Area Under the Concentration Time Curve [AUC(Res%)]
• Plasma Decay Half-Life (t1/2)

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes are measurements expressed on a numerical scale. For the primary endpoint, the registry reports the mean and standard deviation for each formulation. A mean describes the group’s average value. A standard deviation describes how dispersed individual measurements are around that average; it is not the uncertainty in the estimated mean and it is not a confidence interval.

What does the mean difference describe?

The recalculated mean difference is formed by comparing the posted treatment means, with the tablet treated as the comparison of interest and the capsule as the reference. Its units remain ng*h/mL. A positive estimate means the posted tablet mean is higher; a negative estimate would mean it is lower. The estimate of 22.2 is accompanied by a confidence interval, because a point estimate alone does not convey the range of values compatible with the data under the calculation’s assumptions.

This recalculation uses unadjusted summary statistics. It does not include participant-level pairing, period effects, or sequence effects. In a crossover design, each participant may contribute information under both treatments, and the within-participant relationship can affect the uncertainty of a treatment contrast. The summary statistics posted by treatment do not contain that relationship. The recalculated standard error, confidence interval, and p-value therefore should not be mistaken for a reconstruction of the original crossover analysis.

What does a confidence interval mean?

General explanation: a confidence interval is a range produced by a statistical procedure that reflects uncertainty in an estimated quantity. A narrower interval indicates greater precision under the assumptions of that procedure; a wider interval indicates less precision. It does not show all possible values with equal plausibility, and it does not account for methodological choices or missing information that the analysis did not model. The recalculated 95% interval applies to the unadjusted mean difference. The sponsor’s 90% interval applies to its ratio of adjusted means. Those intervals describe different quantities and should not be compared as if they were interchangeable.

What does the p-value describe?

General explanation: a p-value measures how incompatible the observed result is with a specified null hypothesis under the statistical model and its assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. The recalculated primary comparison has an unadjusted p-value of 0.588. The sponsor’s analysis has no p-value reported in the registry record. The p-value from the recalculation does not by itself answer a bioequivalence question, which ordinarily depends on a defined comparison scale and acceptance criteria.

Why do crossover details matter?

General explanation: crossover analyses can use the fact that measurements from the same participant are related. Pairing can reduce or increase the uncertainty of a contrast depending on how strongly outcomes within a participant are related. Period and sequence can also matter if outcomes vary over time or if the preceding treatment influences later measurements. The registry identifies a randomized, two-period crossover design, but the original model, treatment sequences, period handling, and washout details are not reported in the registry record. The recalculated comparison does not fill in those missing design details.

How should the sponsor result be read?

The sponsor reports a ratio of adjusted means rather than a difference of unadjusted means. A ratio expresses one adjusted mean relative to another and is reported as a percentage. The accompanying 90% confidence interval describes uncertainty in that ratio under the sponsor’s analysis. The registry does not identify the model or adjustment variables, and no p-value is posted for this result. The ratio and its interval should therefore be described as the sponsor’s reported adjusted analysis, without attributing an unreported method to it.

General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, its uncertainty estimates may be too small and its intervals too narrow. The registry does not report an over-dispersion assessment or a model that would allow this issue to be evaluated, so no conclusion about over-dispersion is possible for this trial.

The posted calculations are not the trial’s original sample-size design or a report of observed power. They are planning illustrations based on the observed effects and stated assumptions. The original sample-size justification and the trial’s planned significance level are not reported in the registry record. The illustrations should be read as hypothetical planning aids rather than evidence that the completed study had a particular probability of detecting an effect.

11. Confidence Intervals and Precision

Precision is conveyed by the confidence interval around an estimate, not by the estimate alone. For the recalculated primary mean difference, the 95% interval extends from -58.04 to 102.4 ng*h/mL. It includes zero and spans both a possible lower tablet mean and a possible higher tablet mean relative to the capsule mean. This breadth indicates that the unadjusted summary-statistic comparison does not locate the difference precisely.

The sponsor’s adjusted ratio is 104.86%, with a 90% confidence interval from 100.12% to 109.83%. That interval is expressed on a ratio scale, whereas the recalculated interval is expressed as a difference in ng*h/mL. They are not direct alternatives: they arise from different analyses, estimate different quantities, and use different confidence levels. The registry does not report enough detail about the sponsor’s model to determine how its adjustment affects precision.

Confidence intervals describe uncertainty conditional on the analysis and its assumptions. They do not account automatically for unreported features of the design, an unreported analysis plan, or missing observations. In this crossover study, the lack of posted participant-level paired data and model details prevents a full assessment of how the within-participant structure contributed to the sponsor’s precision estimate.

Neither interval alone establishes a formal bioequivalence conclusion. The registry record does not report the applicable acceptance limits or a complete decision rule. Precision is therefore best described in terms of the estimates and their stated intervals, without converting them into a claim that the formulations meet or fail an unreported criterion.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed effect, not the trial’s original design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column describes a hypothetical design that, under those assumptions and for the selected effect, would have an 80% probability of detecting an effect according to the calculation’s decision rule. The 90% power column uses a higher target probability under the same general planning framework. These are planning targets, not guarantees: actual performance would depend on whether the assumptions and effect size are realistic and whether the eventual study is analyzed as planned.

The rows describe planning for the full observed effect and for smaller fractions of that effect. Smaller effects are harder to distinguish from ordinary sampling variability, so they require more participants under the same assumptions. The figures should be read as sensitivity illustrations: they show how a hypothetical planning requirement changes when the target effect changes. They are not observed power for this completed study, and they do not show that the study was adequately or inadequately designed.

The trial is a crossover study, while these illustrations assume equal allocation between two arms. The planning method therefore should not be treated as a reconstruction of the original crossover design calculation. The registry record does not report the original design assumptions or sample-size justification.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 22.200; pooled standard deviation σ = 158.554.
2. n = 2 × (1.96 + 0.842)² × 158.554² / 22.200² = 800.7, rounded up to 801 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 22.2                      # observed difference in means
sigma <- 158.554122620637                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1235195)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 801 (80% power), 1,072 (90% power)
 75% of observed effect: n per arm = 1,424 (80% power), 1,906 (90% power)
 50% of observed effect: n per arm = 3,203 (80% power), 4,288 (90% power)
power.t.test: 801.7 
Simulated power at n = 801 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s primary analysis reports a ratio of adjusted means of 104.86%, with a 90% confidence interval from 100.12% to 109.83%. No p-value is reported for this analysis. It is distinct from the recalculated unadjusted mean difference of 22.2 ng*h/mL and its 95% confidence interval from -58.04 to 102.4. One result is a ratio of adjusted means; the other is a difference calculated from the posted treatment summaries.

The adjusted result is the sponsor’s own analysis and should be identified as such. The registry record does not report the method used, the adjustment factors, or enough detail to reproduce that analysis. The summary-statistic recalculation does not use the crossover pairing and is not a substitute for the sponsor’s model. The registry does not flag a discrepancy between the posted results and recalculation, but the two analyses still answer the comparison using different scales and methods.

The sponsor’s interval is an estimate of precision for its adjusted ratio; the recalculated interval describes uncertainty for an unadjusted difference. Neither result can be turned into a formal bioequivalence determination from the registry information alone because the decision limits and full analysis plan are not reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

The registry record does not report whether the statistical plan adjusted for testing multiple outcomes, whether an outcome hierarchy was prespecified, or whether any interim analyses were planned or conducted. No interim-analysis information is reported in the registry record. The primary endpoint is identified, and secondary outcomes are named, but that information alone does not establish how multiple comparisons were handled.

General explanation: multiplicity arises when several hypotheses or outcomes are examined. Without an adjustment or an appropriate prespecified strategy, repeated testing can increase the chance of a result appearing notable by chance. This does not mean that any particular posted result is false; it means secondary findings should be interpreted with awareness that the testing framework is not described. The registry provides no basis for applying an unreported correction after the fact.

The primary outcome description identifies the pharmacokinetic population as all treated participants with at least one sertraline concentration. The registry does not report how many participants lacked usable primary measurements, whether any participants were excluded from particular analyses, or how missing concentrations or incomplete profiles were handled. It also does not report whether all randomized participants were analyzed according to their assigned sequence.

Missing observations can affect both the estimated treatment effect and its precision, depending on why measurements are missing and how the analysis handles them. General explanation: an analysis based on complete observations may be biased if the likelihood of missingness is related to the outcome or treatment, while other approaches rely on assumptions about the missing-data process. The registry record does not provide the information needed to assess such assumptions or determine which approach was used.

The registry does not report the full protocol statistical plan, the original sample-size justification, the analysis model for the crossover structure, or the handling of period and sequence. These omissions prevent a thorough audit of prespecification and of the relationship between the reported analysis and the planned analysis. They should be understood as limits on what can be established from the registry record, not as evidence that a particular procedure was or was not performed.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events for the hard gelatin capsule group and zero for the film-coated tablet group. It also reports other adverse events for 11 participants in the capsule group and 13 participants in the tablet group. These are descriptive counts from the posted safety results; the registry record does not provide details about event types, severity grading, or attribution to treatment.

Zero reported serious adverse events in these groups does not establish that no risk exists. The study enrolled 30 participants, and its design and duration were focused on single-dose pharmacokinetic assessment. The registry does not report death counts, so deaths are not reported in the registry record. It also does not provide enough detail in the posted figures to infer whether an event occurred during a particular period or whether participants experienced events under both formulations.

These safety counts should be read as descriptive observations, not as a comparative safety estimate. The study is not a basis for broad conclusions about adverse events in other populations or with other patterns of use.

17. What the Result Does, and Does Not, Mean

The results describe pharmacokinetic exposure after a single 50 mg dose of two sertraline hydrochloride formulations in healthy participants under fasted conditions. The primary endpoint is an exposure measure through 72 hours. The sponsor reports an adjusted ratio with a 90% confidence interval, while a separate unadjusted summary-statistic recalculation reports a mean difference and 95% confidence interval. These results provide estimates for this study and these conditions.

They do not establish a clinical benefit or lack of benefit, and they do not show that one formulation is clinically superior to the other. The endpoint is a concentration-based pharmacokinetic measure, not a clinical outcome. Nor can the posted values alone establish formal bioequivalence: the registry record does not report the acceptance limits or full statistical decision rule needed to interpret the ratio against such criteria.

The study’s conditions constrain interpretation. It was a single-dose comparison under fasted conditions in healthy participants. The registry results do not establish exposure under fed conditions, with repeated dosing, or in populations not represented by the listed study participants. The registry also does not provide details needed to assess treatment sequence, period effects, missing measurements, or the sponsor’s adjustment model.

The recalculated interval includes zero, while the sponsor’s ratio interval is reported on a different scale and from an adjusted analysis. These are not contradictory statements simply because their values look different: they estimate different quantities using different approaches. The sponsor’s analysis remains the registry’s reported analysis; the re-calculation is an unadjusted illustration from group summaries. The correct interpretation is limited to describing what each estimate and interval say under its respective method, without overstating the evidence.

The posted results also do not imply that uncertainty has been eliminated. Confidence intervals reflect sampling uncertainty under assumptions, and unreported design or analysis details cannot be recovered from the group means and standard deviations. The most defensible conclusion is descriptive: the registry records exposure estimates for both formulations and reports an adjusted ratio, but the public record does not contain enough methodological detail to independently verify a formal bioequivalence determination.

18. Why This Trial Matters Statistically

This trial illustrates why the design and estimand matter when interpreting a treatment comparison. A crossover study is structured to compare formulations within participants, whereas the simplest calculation from treatment-level means and standard deviations does not use the participant-level pairing. The resulting unadjusted interval is useful as a transparent summary-statistic illustration, but it is not necessarily the same inference as a crossover model.

It also demonstrates the importance of distinguishing a difference from a ratio. A difference is expressed in the endpoint’s original units, while a ratio of adjusted means is expressed relative to a reference mean. The sponsor’s adjusted ratio and the recalculated mean difference are not interchangeable, even though both concern the same primary outcome. Interpretation depends on knowing the target estimand, adjustment method, and decision criteria.

Bioequivalence questions are not answered simply by observing similar-looking means or by noting that an interval includes or excludes a particular value. The acceptance limits and analysis procedure must be specified. Those criteria are not reported in the registry record, illustrating how incomplete statistical reporting can prevent readers from determining whether a pharmacokinetic comparison meets its intended standard.

Finally, sample-size illustrations based on an observed effect should not be confused with original planning or observed power. They answer a hypothetical question under stated assumptions. Separating planning calculations from the completed study’s results helps prevent retrospective power claims from being mistaken for evidence about the quality or conclusiveness of the study.

19. 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 leaves several trial-specific limitations unresolved. It does not report the original sample-size justification, the treatment sequences, the interval between periods, or the washout details. Without those details, readers cannot assess the extent to which period, sequence, or carryover considerations informed the analysis.

The sponsor’s adjusted analysis is reported as a ratio of adjusted means, but its statistical method and adjustment variables are not described. Participant-level paired results are also not available in the posted summaries. As a result, the recalculated unadjusted comparison cannot reproduce the crossover analysis or show how within-participant information affected the sponsor’s estimate and precision.

The registry record does not report the formal bioequivalence limits, a complete decision rule, or a full statistical analysis plan. It also does not report how missing pharmacokinetic measurements were handled, whether any participants were excluded from particular analyses, or the number of participants with incomplete profiles. The details needed to assess multiplicity and any interim analyses are likewise not reported in the registry record.

The available results cover the primary endpoint and some secondary measures, but numerical findings for time to maximum observed plasma concentration and residual area under the concentration-time curve are not reported in the registry record. Safety reporting is also limited: the posted counts do not include event descriptions or attribution details, and death counts are not reported. These gaps limit independent assessment of the full pharmacokinetic and safety record.

These limitations do not determine what the unreported methods or results would have shown. They mark where the registry record does not permit a fuller evaluation. Interpretation should remain specific to the posted outcomes, population, and fasted single-dose conditions.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions — NCT01235195.
• Registry record last updated 2021-01-27; status last verified 2021-01.
• Results first posted 2012-05-07.
• 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.

23. Record Summary

The completed Phase 1 study randomized healthy participants in an open-label, single-dose, two-treatment, two-period crossover comparison of sertraline hydrochloride 50 mg as a hard gelatin capsule and as a film-coated tablet under fasted conditions. The registry reports 30 participants enrolled and 30 observations for each treatment on the primary outcome, area under the concentration-time curve from predose to 72 hours.

The sponsor’s primary result is a ratio of adjusted means of 104.86%, with a 90% confidence interval from 100.12% to 109.83%; no p-value is reported for that analysis. An unadjusted recalculation gives a mean difference of 22.2 ng*h/mL, with a 95% confidence interval from -58.04 to 102.4 and an unadjusted p-value of 0.588. These results use different scales and methods.

The registry record does not report the formal bioequivalence limits or enough detail to reconstruct the sponsor’s model. The results describe exposure under the study conditions and do not, by themselves, establish a formal bioequivalence conclusion or a clinical outcome.