Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects (NCT01055769), a randomized phase 1 study. The primary outcome is Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast).

2. Clinical Question

3. Trial Design

This was a Phase 1 randomized, open-label, single-dose, 2-way crossover bioequivalence study. It compared linezolid 600 mg oral suspension with linezolid 600 mg tablet in healthy Chinese male subjects. The registry reports enrollment of 20 and a completed study. The study began in 2010-03, with primary completion in 2010-04.

In a crossover design, each participant receives both treatments in separate periods. Participants were assigned to one of two treatment sequences: oral suspension followed by tablet, or tablet followed by oral suspension. The registry specifies a 4-day washout between the treatment periods. This design allows each participant’s observations under the two formulations to be compared, while accounting for the fact that the measurements come from the same person rather than from unrelated groups.

The study was open label, so masking was not used. The registry does not report the number of participants assigned to each sequence, the number who completed both periods, or whether any participants were excluded from particular analyses. Although the enrollment was 20, the posted summaries give n=20 for each treatment; these are treatment-specific observations in a crossover study, not evidence of 40 distinct participants.

The primary pharmacokinetic endpoint was AUClast. Blood sampling was scheduled at 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose. The registry also identifies secondary pharmacokinetic outcomes. Further details about the protocol, sample-size rationale, and the original statistical plan are not reported in the registry record.

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 Atleast 4 Days

Second Intervention

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.

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 Last Quantifiable Concentration (AUClast), measured over 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.

AUClast is the area under the plasma concentration-time curve from time zero, before dosing, to the time of the last measurable concentration. It condenses concentration measurements across the observation period into a measure of total drug exposure up to that last quantifiable measurement. The endpoint is reported in microgram*hour/milliliter (mcg*h/mL).

For a comparison of formulations, exposure is relevant because it describes how much drug is present in plasma over time, rather than relying on a single concentration measurement. The registry reports AUClast as a mean with standard deviation for each treatment, and also includes the sponsor’s adjusted geometric means ratio analysis. These summaries describe different aspects of the comparison: the means and standard deviations describe the posted values in their original scale, while the adjusted geometric ratio is the sponsor’s reported formulation comparison.

The sampling schedule ran through 48 hours post-dose, with measurements at the registry-listed time points. The endpoint does not by itself describe every feature of the concentration-time profile. Other listed pharmacokinetic measures include AUC from time zero to extrapolated infinite time, time to maximum observed plasma concentration, and terminal half-life. The registry’s clinical question concerns bioequivalence, but the equivalence margin and details of how the sponsor applied its decision criterion are not reported in the registry record.

7. Results Posted in the Registry

• Linezolid 600 mg Tablet: mean 112.00 versus 108.90 on control; difference 3.10 (95% CI -11.31 to 17.51), standardized effect d = 0.13; z-test p = 0.673.

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:
  • Linezolid 600 mg Tablet: mean 112.60 versus 109.20 on control; difference 3.40 (95% CI -11.09 to 17.89), standardized effect d = 0.15; z-test p = 0.646.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Linezolid 600 mg Tablet and the control. The interval gives the range of effects that remain compatible with the data.

Terminal 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:
  • Linezolid 600 mg Tablet: mean 5.13 versus 5.08 on control; difference 0.05 (95% CI -0.46 to 0.56), standardized effect d = 0.06; z-test p = 0.847.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Linezolid 600 mg Tablet and the control. The interval gives the range of effects that remain compatible with the data.

The secondary pharmacokinetic outcomes listed in the registry include AUC from time zero to extrapolated infinite time, time to reach maximum observed plasma concentration, and terminal half-life. Numerical summaries are posted for AUC to infinity and terminal half-life. Numerical results for time to maximum observed plasma concentration are not reported in the registry record.

At a broad level, the posted secondary summaries are consistent with the primary endpoint in presenting treatment-specific pharmacokinetic measures for the two formulations. The sponsor’s adjusted geometric means ratio for AUC to infinity is 97.65, with a 90% confidence interval from 92.92 to 102.63. The terminal half-life summaries and unadjusted comparison are also posted, but there is no sponsor-reported analysis listed for that endpoint. These secondary results provide additional context about exposure and disposition, but they do not replace the prespecified primary AUClast comparison.

Secondary analyses generally carry less weight than a primary analysis when multiple outcomes are examined. In general, testing many outcomes can increase the chance of apparently notable results arising by chance if no adjustment or hierarchy is used. The registry does not report a multiplicity procedure, a hierarchy among the secondary outcomes, or whether all planned secondary analyses are included. It is therefore appropriate to describe the posted secondary findings as supportive context rather than as independent confirmation of the primary result.

The available secondary information is incomplete: one listed outcome lacks numerical results in the registry record, and the record does not explain why. The endpoint-specific summaries should be interpreted with that reporting gap in mind. No additional conclusion about the formulations should be drawn from unreported results or from multiplicity-adjusted claims that are not documented.

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

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

9. Statistical Interpretation

10. Statistical Methods Explained

The registry presents continuous pharmacokinetic outcomes as means and standard deviations. For AUClast, it also reports a sponsor analysis using an adjusted geometric means ratio and a 90% confidence interval. Separately, simple unadjusted recalculations compare the reported treatment means. These are distinct analyses with different estimands and assumptions, and should not be read as duplicate versions of the same calculation.

What does the mean difference describe?

The mean difference is the tablet mean minus the oral suspension mean. For AUClast, the recalculated difference is 3.1 mcg*h/mL. This describes the separation between the posted arithmetic means. Its confidence interval expresses uncertainty around that estimate under the simple recalculation. The interval extends from -11.31 to 17.51, which includes zero. The unadjusted p-value is 0.673. The p-value is a measure of how compatible the observed summary is with a null hypothesis of no difference under the calculation’s assumptions; it does not provide the probability that the null hypothesis is true, and it does not test equivalence.

The recalculation is based on posted summary statistics. In a crossover study, outcomes from the same participant across treatment periods are paired. A calculation based only on separate means and standard deviations does not use the within-participant covariance. It also cannot account for period, sequence, or other model terms unless those are incorporated into the calculation. The registry does not provide the participant-level data or the sponsor’s method, so the posted summaries cannot be used to reconstruct those elements.

Why is the sponsor’s ratio a different result?

The sponsor reports an adjusted geometric means ratio of 97.81, with a 90% confidence interval from 93.11 to 102.75. A geometric ratio compares treatment summaries on a multiplicative scale, and an adjusted result may account for design features or model terms. That general description does not identify the exact transformation or model used in this study. The method is not reported in the registry record.

The registry labels this result as a non-inferiority or equivalence analysis, but does not state the margin or decision criterion. In general, an equivalence assessment compares the uncertainty interval with prespecified acceptable bounds. A ratio near the reference value alone is not enough to establish equivalence: the margin, confidence interval, and analysis plan all matter. The posted ratio and interval are therefore important evidence, but the record does not contain every detail needed to independently reproduce the sponsor’s conclusion.

What does a confidence interval convey?

In general, a confidence interval represents uncertainty in an estimated quantity under the statistical model and procedure used to construct it. It communicates a range of estimates compatible with the data and method, rather than guaranteeing that the true value lies within the interval. The AUClast recalculation gives a 95% interval for an unadjusted mean difference, while the sponsor reports a 90% interval for an adjusted geometric means ratio. Because they refer to different quantities, use different scales, and have different stated confidence levels, their endpoints are not directly comparable.

The standard deviations describe spread among the treatment-specific observations. For AUClast they are 21.66 for the suspension and 24.74 for the tablet. Standard deviation is not the same as standard error: standard deviation describes individual-level variability, while standard error describes uncertainty in an estimated summary. The posted recalculation gives treatment-specific standard errors of 4.843 and 5.532, but these are components of the unadjusted summary calculation and do not capture the paired structure of the crossover design.

Why can the crossover structure matter?

General statistical explanation: crossover comparisons can be more informative than an independent-groups comparison when each participant’s measurements under the two treatments are correlated. The paired analysis uses within-person contrasts, which can remove some between-person variation. The benefit and the resulting precision depend on the actual within-person relationship and the model. Those participant-level details are not reported in the registry record. The unadjusted re-calculation is therefore useful as a transparent comparison of posted summaries, but it should not be mistaken for the sponsor’s crossover analysis.

The registry defines the primary pharmacokinetic concentration population as all randomized and treated participants with at least 1 concentration in at least 1 treatment period. The record does not report whether all enrolled participants met that definition, whether the sponsor used any additional analysis populations, or how observations that were absent or below quantification were handled. Those details can affect the interpretation of pharmacokinetic summaries and cannot be inferred from the posted means alone.

Finally, a p-value for a difference and an equivalence analysis answer different questions. Failure to show a statistically detectable difference does not prove that two formulations are sufficiently similar. Conversely, a formal equivalence conclusion depends on a chosen margin and an appropriate analysis. Since the registry gives the sponsor’s ratio and interval but not its margin or method, the most defensible reading is to report the sponsor result as posted, distinguish it from the simple mean-difference recalculation, and avoid extending either result beyond the information documented.

11. Confidence Intervals and Precision

Precision concerns how much uncertainty surrounds an estimate, not whether the estimate is clinically important or whether a formal criterion has been met. For the unadjusted AUClast mean difference, the estimate is 3.1 mcg*h/mL and the 95% confidence interval runs from -11.31 to 17.51. The interval includes both negative and positive values, indicating that the recalculation is compatible with a range of directions and magnitudes for the arithmetic mean difference under its assumptions. It is not an equivalence interval and cannot establish equivalence without the relevant prespecified bounds.

The sponsor’s adjusted geometric means ratio is 97.81, with a 90% confidence interval from 93.11 to 102.75. This is a ratio-scale result, not a mean difference, and its interval is reported at a different confidence level from the recalculated difference. The registry does not give the equivalence margin, so the interval’s relation to the sponsor’s decision bounds cannot be assessed from the record alone.

The enrolled sample was 20, and the treatment summaries each report n=20. The size of the intervals reflects both the observed variability and the analysis used. A crossover analysis may use within-participant information, whereas the simple recalculation from separate summary statistics does not. The registry does not report the within-participant covariance or the sponsor’s analysis method, so the precision of the sponsor’s adjusted result cannot be independently reproduced.

Confidence intervals are generally more informative than a p-value alone because they show the range of estimates compatible with a specified method. They still depend on assumptions and do not account for unreported design choices, missing observations, or multiplicity. Precision should therefore be interpreted alongside the crossover structure, the difference between the sponsor analysis and recalculation, and the missing details in the registry record.

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 sample-size figures are planning illustrations based on the observed effect, not the study’s original enrollment rationale. For continuous outcomes, the figures are participants per arm; they are not total event counts. The illustrations assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions. The 90% power column gives the corresponding planning figure for a 90% chance. Power is conditional on the assumed effect, variability, test, and other planning assumptions; it is not a guarantee of a result.

For the primary AUClast comparison, the planning rows are labeled as planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The figures increase as the assumed effect becomes smaller. This reflects a general statistical principle: a smaller difference is harder to distinguish from background variability, so more participants are needed to achieve the same target power under a given design and analysis.

These numbers are not observed power. They are hypothetical planning estimates derived from the observed effect and specified assumptions, and they should not be interpreted as evidence about the probability that the completed trial succeeded. The original study used a crossover design, whereas the planning assumptions describe equal allocation between two arms; the registry does not report whether the original design calculation used these assumptions or how it accounted for paired measurements.

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 = 3.100; pooled standard deviation σ = 23.251.
2. n = 2 × (1.96 + 0.842)² × 23.251² / 3.100² = 883.1, rounded up to 884 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 <- 3.09999999999999                      # observed difference in means
sigma <- 23.2510558900021                     # 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(1055769)
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 = 884 (80% power), 1,183 (90% power)
 75% of observed effect: n per arm = 1,570 (80% power), 2,102 (90% power)
 50% of observed effect: n per arm = 3,533 (80% power), 4,729 (90% power)
power.t.test: 884 
Simulated power at n = 884 per arm: 0.798 (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 registry reports the sponsor’s adjusted geometric means ratio for AUClast as 97.81, with a 90% confidence interval from 93.11 to 102.75. The result is classified in the record as a non-inferiority or equivalence analysis. The analysis method and the margin used for that assessment are not reported in the registry record, so the exact decision rule cannot be reconstructed from these entries.

The simple recalculation is different: it compares the posted arithmetic means, producing an unadjusted mean difference of 3.1 mcg*h/mL with a 95% confidence interval from -11.31 to 17.51. It does not reproduce the sponsor’s adjusted ratio analysis, and it does not use the participant-level pairing or any unreported model adjustments from the crossover design. The two results answer related but non-identical statistical questions.

The sponsor’s reported analysis is the direct registry result for the stated bioequivalence analysis. The recalculation is best treated as a transparent supplementary comparison of the posted means, not a replacement or correction. Since the discrepancy flag is false, the registry does not indicate a conflict between a sponsor result and the summary calculations. The missing method and margin remain important limits on independent verification.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies AUClast as the primary endpoint and lists several secondary pharmacokinetic outcomes. It does not report whether the statistical plan used a multiplicity adjustment, a testing hierarchy, or another method to control the interpretation of results across endpoints. The sponsor’s analysis method and equivalence margin are also not reported in the registry record.

In general, multiplicity matters when several hypotheses or outcomes are examined. Each additional analysis creates another opportunity for a result to appear noteworthy by chance, so a plan for prioritizing or adjusting comparisons can affect how strongly results should be interpreted. Without a reported approach, the secondary outcomes should be treated as exploratory or supportive rather than as a collection of independent confirmatory tests. This does not imply that any particular result is invalid; it marks a limit on how confidently the family of results can be interpreted.

The record defines the primary pharmacokinetic concentration population as all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. It does not report the number included in that population, participant flow through both crossover periods, exclusions, or the handling of incomplete concentration profiles. The registry also does not describe imputation, treatment of values below quantification, protocol deviations, or sensitivity analyses.

These omissions matter because pharmacokinetic estimates can depend on which observations contribute to the analysis and how incomplete data are handled. In a crossover study, period-specific missingness can also affect whether a participant contributes a paired comparison. The posted treatment summaries alone do not show how such cases were managed.

The registry does not report the protocol’s full statistical analysis plan, interim analyses, or original sample-size justification. No claims about those features can be made from the available record. As a result, the sponsor’s adjusted ratio can be quoted as reported, while independent assessment of the analysis population, multiplicity control, and missing-data decisions remains limited.

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 serious adverse events for 20 participants at risk in each treatment group and 0 affected in each group. It reports no serious adverse event terms. These counts describe the posted serious adverse event results during the study; they do not establish that no events could occur outside the observation and reporting conditions of the trial.

For other adverse events, 0 of 20 participants were affected in the oral suspension group and 1 of 20 in the tablet group. The record does not give a term for that event in the information, so its nature and severity cannot be described. Death counts are not reported in the registry record.

These safety counts come from a small, short, single-dose study in healthy participants. They are descriptive, and the record does not provide detailed event narratives or an analysis comparing safety between treatments. The counts should not be taken as a comprehensive assessment of safety in other populations or settings.

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

The study addresses a focused pharmacokinetic question: how exposure after a single 600 mg dose of linezolid oral suspension compares with exposure after a 600 mg tablet in healthy Chinese male subjects. Its randomized crossover design exposed participants to both formulations in different sequences, with a 4-day washout. The primary measure was AUClast, a summary of plasma exposure through the last quantifiable concentration.

The registry reports the treatment means, their standard deviations, an unadjusted mean-difference recalculation, and the sponsor’s adjusted geometric means ratio with a 90% confidence interval. These results characterize the observed study data. The sponsor’s ratio is identified as a non-inferiority or equivalence analysis, but the margin and method are not reported. Without those details, the criterion behind that classification cannot be independently checked from the registry record.

The unadjusted comparison and sponsor result should not be conflated. One is a simple arithmetic mean difference based on posted summary statistics; the other is an adjusted geometric ratio. The recalculation does not use the paired participant-level data inherent in the crossover design. Neither result alone supports conclusions beyond the endpoint, population, dose, and study conditions described.

The record does not establish how these findings apply to people who were not represented in the study, repeated dosing, different clinical circumstances, or outcomes other than pharmacokinetic measures. It also does not report the full protocol or analysis plan, missing-data methods, or multiplicity strategy. These limitations do not negate the reported observations, but they set boundaries on the conclusions that can be drawn.

Accordingly, the most precise interpretation is that the registry documents a completed small crossover study and reports its AUClast summaries and sponsor ratio. The results can be discussed as evidence from this specific study, while the unavailable decision margin and analysis details prevent a fully independent reconstruction of the formal bioequivalence assessment.

18. Why This Trial Matters Statistically

This trial is statistically notable because it uses a crossover design for a formulation comparison. When the same participant receives both treatments, comparisons can account for stable differences between participants. The design also makes treatment order, period, washout, and within-person correlation relevant to analysis. The registry describes randomized sequences and a 4-day washout, but does not report the statistical model or sequence-specific enrollment.

The record illustrates why the estimand matters. An unadjusted arithmetic mean difference and an adjusted geometric means ratio are not interchangeable descriptions. The first summarizes an absolute difference between treatment means; the second is a ratio-scale result reported for the sponsor’s non-inferiority or equivalence analysis. Readers need to know the scale, adjustment, confidence level, and decision margin to understand what each result can establish.

It also demonstrates the distinction between absence of a detectable difference and evidence of equivalence. A nonsignificant unadjusted test does not establish that treatment differences are acceptably small. A formal equivalence conclusion requires prespecified bounds and an appropriate analysis, and those bounds are not reported in the registry record.

Finally, the registry provides enough information to describe treatment summaries and the sponsor’s reported interval, but not enough to reproduce the full crossover analysis. The contrast between transparent summary-based recalculation and unavailable participant-level model details is a useful reminder that statistical interpretation depends on both numerical results and design-specific methods.

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.

This study enrolled 20 healthy Chinese male subjects and evaluated single doses. The population and conditions are narrow, so the registry results should not automatically be generalized to other populations, repeated dosing, or other settings. The record does not report the number of participants who completed both periods or the number contributing to each analysis population.

The posted treatment means and the unadjusted recalculation do not make use of the participant-level paired data expected in a crossover comparison. The sponsor’s adjusted geometric means ratio is reported, but its method is not. The registry also does not state the equivalence margin or the rule used to interpret the confidence interval. These gaps prevent independent reproduction of the formal analysis and its decision criteria.

Information about missing data, observations below quantification, protocol deviations, period effects, sequence effects, and sensitivity analyses is not reported in the registry record. The registry does not report the original sample-size justification, interim analyses, or a multiplicity strategy. Numerical results for the listed time-to-maximum-concentration outcome are not reported in the registry record.

Safety reporting is limited to the posted counts. The record does not identify the other adverse event term in the material, and deaths are not reported in the registry record. The small study and single-dose setting offer limited information about uncommon events or safety in broader populations. These are limits of the available evidence, not evidence that unreported events or analyses had a particular result.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects — NCT01055769.
• Registry record last updated 2012-02-01; status last verified 2012-01.
• Results first posted 2011-04-05.
• 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

NCT01055769 is a completed Phase 1 randomized, open-label, single-dose, 2-way crossover study sponsored by Pfizer. It enrolled 20 healthy Chinese male subjects and compared linezolid 600 mg oral suspension with a 600 mg tablet, with a 4-day washout between treatment periods.

The primary endpoint was AUClast. The registry reports treatment means and standard deviations, a sponsor-adjusted geometric means ratio of 97.81 with a 90% confidence interval from 93.11 to 102.75, and a simple unadjusted mean-difference recalculation. The registry does not report the sponsor’s analysis method or equivalence margin. Secondary results are posted for AUC to infinity and terminal half-life; numerical results for time to maximum observed plasma concentration are not reported in the registry record.

The record reports 0 serious adverse events in each treatment group and 1 other adverse event in the tablet group. Death counts are not reported in the registry record.