Venlafaxine 25 mg Tablets Under Non-Fasting Conditions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Venlafaxine 25 mg Tablets Under Non-Fasting Conditions (NCT00834249), a randomized phase 1 study. The primary outcome is Cmax - Maximum Observed Concentration - Venlafaxine in Plasma.

2. Clinical Question

The clinical question is therefore a pharmacokinetic comparison under fed conditions, not a comparison of clinical benefit or safety outcomes. Because each sequence includes both products in separate periods, this is a crossover study: treatment comparisons can be made within the study design, but interpretation depends on how period, sequence, and within-subject information were handled in the analysis. Those analytical details are not reported in the registry record. The posted summary statistics give group means and standard deviations, while the sponsor's legacy analysis reports a test/reference ratio of least-squares means. These summaries address related comparisons but are not interchangeable measures of the same statistical model.

3. Trial Design

The registry describes a completed, randomized, unmasked, 2-way crossover bioequivalence study in healthy subjects. The study began in 2002-12 and primary completion was recorded in 2002-12. The sponsor was Teva Pharmaceuticals USA. The record gives enrollment as 18 and identifies the study as Phase 1.

Participants were assigned to one of two treatment sequences. The Venlafaxine sequence received venlafaxine 25 mg tablets in the first period followed by Effexor® 25 mg tablets in the second period. The Effexor® sequence received the reference product first and venlafaxine second. Both products were administered as one 25 mg tablet under fed conditions. The record does not report the method used to generate or conceal the randomization sequence, the duration of either period, or whether a washout interval was used.

A crossover design differs from a parallel-group comparison because each sequence receives both products at different times. In general, such designs can use within-participant comparisons, while also requiring attention to period and sequence effects. That is general statistical context; the registry record does not describe how these design features were handled in the sponsor's model. It lists the primary analysis population as data from all subjects who completed the study. The summary results report 15.0 for each sequence group, but the record does not explain the difference between enrollment and the reported analysis counts or provide reasons for noncompletion.

The record reports a primary outcome for venlafaxine Cmax and three posted secondary outcomes for O-desmethylvenlafaxine. The exact protocol, sample-size justification, analysis model, and any interim analyses 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: 7 Days

Reasons for not completing this period:

Second Intervention

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data from all subjects who completed the study were included in the statistical analysis.

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 Cmax - Maximum Observed Concentration - Venlafaxine in Plasma, measured over Blood samples collected over 24 hour period.

The primary endpoint is maximum observed concentration (Cmax) of venlafaxine in plasma, measured in ng/mL. Blood samples were collected over a 24 hour period. Cmax is the highest measured concentration in the sampling profile. As a general pharmacokinetic concept, it is used to describe peak exposure and can inform comparisons of the rate and extent of absorption. In this study, the registry specifically describes bioequivalence as based on Cmax.

The posted mean is 47.13 ng/mL for the Venlafaxine sequence and 46.45 ng/mL for the Effexor® sequence. The corresponding standard deviations are 18.19 and 20.28. These are descriptive summaries of the observed endpoint; the standard deviations describe variability among observations, not uncertainty in the difference itself.

The endpoint's role should be kept distinct from the formal bioequivalence decision. A comparison of means alone does not establish whether the products met an acceptance criterion. Such a conclusion depends on the prespecified analysis and decision limits. The sponsor's analysis reports a test/reference ratio of least-squares means multiplied by 100, but its confidence limits and the acceptance limits are not reported in the registry record. The summary-statistic recalculation gives a mean difference and interval, which describe the data in a different form and do not replace the sponsor's bioequivalence analysis.

7. Results Posted in the Registry

• Effexor®: mean 46.45 versus 47.13 on control; difference -0.68 (95% CI -14.47 to 13.11), standardized effect d = -0.04; z-test p = 0.923.

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.

Cmax - O-Desmethylvenlafaxine in Plasma

• 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:
  • Effexor®: mean 69.17 versus 75.15 on control; difference -5.98 (95% CI -29.01 to 17.05), standardized effect d = -0.19; z-test p = 0.611.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Effexor® and the control. The interval gives the range of effects that remain compatible with the data.

AUC0-inf - O-desmethylvenlafazine in Plasma

• 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:
  • Effexor®: mean 1,315 versus 1,390 on control; difference -75.41 (95% CI -471.86 to 321.04), standardized effect d = -0.14; z-test p = 0.709.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Effexor® and the control. The interval gives the range of effects that remain compatible with the data.

AUC0-t - O-desmethylvenlafaxine in Plasma

• 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:
  • Effexor®: mean 960.47 versus 1,016 on control; difference -55.77 (95% CI -353.90 to 242.36), standardized effect d = -0.13; z-test p = 0.714.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Effexor® and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover O-desmethylvenlafaxine Cmax, AUC0-inf, and AUC0-t. Each has a sponsor-reported test/reference ratio of least-squares means multiplied by 100, and an unadjusted mean-difference recalculation. Across the secondary outcomes, the sponsor ratio estimates are above 100, while the recalculated differences are negative because the contrast is expressed as Effexor® minus Venlafaxine. Those features are consistent with the posted group means on their respective scales, but they do not make the analyses interchangeable.

At a broad level, the secondary results point in the same general direction as the primary summaries: the posted means for the Venlafaxine sequence are higher than those for the Effexor® sequence, and the reported ratios are above 100. The secondary estimates do not replace the primary Cmax result, which is the endpoint identified for the primary question. They add information about metabolite concentration and exposure measures, but the registry record does not report a formal hierarchy or a confirmatory role for these outcomes.

Unadjusted secondary comparisons carry less weight when several outcomes are examined because repeated testing can increase the chance of apparently noteworthy findings arising by chance. As general statistical context, multiplicity procedures can control that risk, but the record does not report whether any adjustment or prespecified testing strategy was used. The secondary p-values are unadjusted, and the sponsor's ratio confidence limits are not reported. Consequently, these results are best treated as supportive descriptive evidence rather than independent confirmation of the primary comparison. The registry record also lists six outcome measures and six analyses, but the details of all measures are not reported in the registry record.

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

• Cmax - O-Desmethylvenlafaxine in Plasma
• AUC0-inf - O-desmethylvenlafazine in Plasma
• AUC0-t - O-desmethylvenlafaxine in Plasma

9. Statistical Interpretation

10. Statistical Methods Explained

The study is a randomized crossover comparison. In a crossover design, participants receive different treatments in separate periods, and treatment sequence determines the order. As general statistical context, the design can allow each participant's response under one treatment to be compared with that participant's response under another. This may remove some between-participant variability from a treatment contrast. The benefit depends on appropriate analysis and on assumptions about period effects, carryover, and other design features. The registry record gives the two sequences but does not report how these features were modeled or assessed.

What do the posted means describe?

The primary outcome is continuous: it is a measured concentration, summarized by a mean and standard deviation. The Venlafaxine sequence mean is 47.13 ng/mL with a standard deviation of 18.19, and the Effexor® sequence mean is 46.45 ng/mL with a standard deviation of 20.28. A mean describes the center of the observed values. A standard deviation describes their spread around the mean. It is not the standard error of the treatment contrast and should not be read as a confidence interval for the mean.

The registry also posts an unadjusted recalculation of the mean difference, with a pooled standard deviation of 19.26 and a standardized difference of -0.035. These are summary-statistic calculations, not estimates from a reported crossover model. The contrast is expressed as Effexor® minus Venlafaxine, so a negative value means the posted Effexor® mean is lower. The recalculation does not incorporate the paired structure unless that information is reflected in the summary inputs; the registry record does not provide paired covariance information.

Why can the crossover analysis differ from the recalculation?

In a crossover analysis, the treatment contrast may use within-participant differences and may account for period or sequence. The standard error can differ from one computed from group means and standard deviations alone because the within-participant correlation affects the variability of paired differences. A model may also report adjusted least-squares means rather than raw means. The sponsor's reported parameter is a test/reference ratio of least-squares means multiplied by 100. The registry record does not identify the statistical method used to obtain that ratio, so it is not possible to reconstruct or fully assess the model from the registry entry.

Accordingly, the simple recalculation serves as an unadjusted check on the posted summaries. It should not be interpreted as a correction of the sponsor analysis or as a substitute for a crossover-specific analysis. No discrepancy is flagged in the registry record. In general, when a reported sponsor analysis and a simple recalculation differ, the sponsor's own analysis takes precedence for interpretation of the trial's prespecified analysis; the registry record does not provide enough detail to verify that prespecification.

What does the p-value answer?

The unadjusted p-value of 0.923 accompanies the recalculated mean-difference comparison. In general, a p-value measures how compatible the observed data are with a specified null hypothesis under the assumptions of the test. It is not the probability that the null hypothesis is true, nor is it a measure of the chance that the treatments are equivalent. The registry record does not report the recalculation's confidence level or a full model specification. More importantly, a test of no mean difference does not establish equivalence: equivalence requires prespecified bounds and an analysis that assesses whether uncertainty lies within those bounds.

How should the ratio analysis be understood?

The sponsor-reported analysis gives a test/reference ratio of least-squares means multiplied by 100. A value of 100 on that scale corresponds to equal estimated means in the ratio analysis. The posted primary estimate is 101.73. The record labels the analysis as a legacy non-inferiority or equivalence type, but does not post the confidence limits, method, or decision bounds. A point estimate near 100 therefore describes the estimated ratio but is not enough to determine whether the ratio met a bioequivalence rule. The same caution applies to the posted secondary ratio estimates.

In general, confidence intervals express a range of values compatible with the data and the analysis assumptions. The recalculated interval for the mean difference is -14.47 to 13.11. Because the interval includes zero, it does not establish a nonzero difference under that comparison. Its span also matters: an interval that includes zero may still include differences in either direction that are not ruled out by the data. The registry does not report the equivalence margin needed to judge whether that span is acceptable for bioequivalence.

What information is missing for a full methods assessment?

The registry record does not report a detailed statistical analysis plan, the crossover model, treatment of period or sequence, handling of missing observations, the ratio analysis confidence limits, or the equivalence limits. It also does not report the study's original sample-size assumptions or a justification for the enrollment target. These absences constrain assessment of the formal analysis; they do not mean that the study necessarily lacked such procedures. They are simply not reported in the registry record.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -0.68 ng/mL, with an interval from -14.47 to 13.11. The interval crosses zero, so the recalculation does not isolate a difference in one direction. Its breadth is important: the summaries are compatible with a range of possible mean differences, rather than only values close to the point estimate. The interval's confidence level is not reported in the registry record, so it should not be assigned a confidence percentage from this entry.

As general statistical context, a confidence interval reflects both the observed estimate and its uncertainty under the analysis assumptions. It is not a range containing a fixed proportion of individual participants' concentrations, and it is not a probability statement about the particular true effect after the data have been observed. Precision depends on variability, information available, and the statistical model. The posted standard deviations describe dispersion in observations; they do not by themselves communicate the precision of the treatment comparison.

The crossover design could use within-participant information in a model, but the posted summary-statistic recalculation does not report that model. Its interval therefore should not be treated as the sponsor's crossover-model interval. The sponsor reports a primary ratio estimate of 101.73, but its 90% confidence limits are not reported in the registry record. Without those limits and the bioequivalence bounds, the precision of the sponsor's ratio estimate cannot be judged against the formal criterion.

Thus, the primary point estimates are close on their respective scales, but the available intervals do not establish bioequivalence. The main limitation is not simply whether the point estimates are similar; it is whether the relevant uncertainty is sufficiently contained within prespecified decision bounds. Those bounds and the sponsor interval are not reported.

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 illustrations based on the observed effect, not the original design calculation. For these continuous outcomes, the figures are participants per arm, not total events. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect. The trial's own original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the illustrative participants per arm for a design with an 80% chance of detecting the specified effect under the planning assumptions, if that effect and those assumptions were correct. The 90% power column gives the corresponding illustrative number for a higher target chance of detection. These are design-planning concepts; they do not describe the chance that the completed trial found a result or the probability that its conclusion is correct.

For each outcome, the planning scenarios consider 100%, 75%, and 50% of the observed effect. The smaller the effect a future study aims to detect, the more participants it generally needs, all else held constant. The figures rise across the scenarios that assume a smaller fraction of the observed effect. Each outcome has its own observed variability and effect estimate, so its planning figures differ. The curve should be read as a visual representation of the same planning relationship, not as an additional estimate from the trial.

This is not observed power. It is a planning illustration computed from the observed effect and stated assumptions, and it does not recover the trial's actual design rationale or account for unreported crossover-model features.

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 = -0.680; pooled standard deviation σ = 19.263.
2. n = 2 × (1.96 + 0.842)² × 19.263² / -0.680² = 12,597.5, rounded up to 12,598 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 <- -0.68                      # observed difference in means
sigma <- 19.2633654899657                     # 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(834249)
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 = 12,598 (80% power), 16,865 (90% power)
 75% of observed effect: n per arm = 22,396 (80% power), 29,982 (90% power)
 50% of observed effect: n per arm = 50,390 (80% power), 67,458 (90% power)
power.t.test: 12598.5 
Simulated power at n = 12,598 per arm: 0.805 (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 test/reference ratio of least-squares means multiplied by 100 of 101.73. It is labelled as a legacy non-inferiority or equivalence analysis. The registry record gives a 90% confidence level for that reported analysis type, but does not provide the ratio's confidence limits, the method, or the equivalence bounds. The point estimate alone cannot show whether a formal bioequivalence criterion was met.

The recalculation instead compares posted arithmetic means and reports an unadjusted mean difference of -0.68 ng/mL, with an interval from -14.47 to 13.11 and p = 0.923. These statistics are not a direct reproduction of the sponsor's ratio of least-squares means. They use a different scale and the recalculation does not document the crossover model. In particular, the registry record does not provide the within-participant covariance information or model details needed to reconstruct the sponsor result.

No discrepancy is flagged in the registry record. The sponsor's own analysis is the relevant analysis for the trial's formal bioequivalence assessment, while the recalculation is a descriptive, unadjusted check of the posted summary values. Neither the sponsor point estimate without its limits nor the recalculated p-value establishes equivalence. The missing confidence limits and decision bounds prevent a full assessment of the sponsor's formal conclusion from the registry entry.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures and six analyses, identifies Cmax for venlafaxine in plasma as the primary outcome, and posts three secondary outcomes for O-desmethylvenlafaxine. It does not describe a multiplicity adjustment, a hierarchy among the secondary outcomes, or a family of hypotheses for confirmatory testing. The recalculated p-values are unadjusted. Without a reported testing strategy, the secondary p-values should not be interpreted as if they were protected from the increased false-positive risk associated with examining multiple outcomes.

The primary analysis population is described as data from all subjects who completed the study. The registry reports enrollment of 18 and outcome summaries with 15.0 in each sequence group. Reasons for noncompletion, missing outcome values, and the method used to handle missing data are not reported in the registry record. The entries do not establish whether missingness occurred, how it was handled, or whether any sensitivity analysis was performed.

The record does not report whether the analysis followed an intention-to-treat, per-protocol, or other named principle. In bioequivalence studies, analysis populations and protocol deviations can be important to interpretation; that is general context, not a description of procedures in this trial. The registry's completer statement is the available population description, and more detailed inclusion or exclusion rules are not reported.

Other details needed to assess crossover analysis are also absent: the model, treatment of period and sequence, washout information, handling of potential carryover, and the sponsor analysis confidence limits. Interim analyses and the original sample-size justification are not reported in the registry record. These omissions limit independent appraisal of the analysis, but they do not establish that the procedures were absent from the full protocol or study report.

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

The posted data describe a randomized comparison of venlafaxine 25 mg tablets and Effexor® 25 mg tablets under fed conditions in healthy subjects. For the primary outcome, the group means are close, and the unadjusted recalculated difference is small relative to the scale of the measured concentration. The interval around that recalculated difference includes zero and extends in both directions. These findings describe the observed summaries and their uncertainty under the recalculation; they do not demonstrate that the products are equivalent.

Formal bioequivalence is a defined statistical conclusion, not simply a finding that two sample means look similar or that a test for difference has a large p-value. It depends on prespecified acceptance limits and an appropriate analysis, generally evaluated using an interval estimate. The sponsor reports a ratio estimate of 101.73 for the primary outcome, but its confidence limits and the acceptance limits are not reported in the registry record. The formal bioequivalence conclusion therefore cannot be assessed from the posted ratio point estimate alone.

The results also do not address whether either product improves a health outcome, nor do they establish comparative safety. The study's stated purpose concerns pharmacokinetic absorption, and the population is described as healthy subjects. Findings from this setting should not be treated as evidence about clinical outcomes in patients. Further population details and safety results are not reported in the registry record.

The appropriate interpretation is narrow: the record reports similar primary mean concentrations, an unadjusted comparison with substantial uncertainty, and a sponsor ratio point estimate near 100. The registry entry does not provide the information needed to determine whether the sponsor's formal equivalence limits were met. It also does not explain the analysis population difference between enrollment and the displayed group summaries.

17. Why This Trial Matters Statistically

This trial illustrates why design and estimand matter when interpreting statistical summaries. A crossover study administers both products across separate periods, so a treatment comparison may be based on within-participant information. A simple contrast of posted group means does not necessarily capture that paired structure or model period and sequence effects. The recalculated comparison is useful as a transparent summary-statistic check, but it should not be mistaken for the sponsor's crossover analysis.

It also demonstrates the distinction between difference testing and equivalence testing. The primary recalculated p-value addresses a null hypothesis of no mean difference under its assumptions. Bioequivalence asks whether uncertainty is sufficiently contained within defined margins. A point estimate near the reference value, or a p-value that does not indicate a difference, cannot answer that question without the relevant interval and limits.

Finally, the record shows how reporting completeness affects interpretation. A sponsor ratio estimate is posted, but its confidence limits and decision margins are absent; the model and analysis details are also not reported. The reader can describe the observed concentrations and compare the available summaries, while recognizing that a formal bioequivalence conclusion requires information beyond the point estimates. This distinction helps keep descriptive evidence, model-based inference, and a regulatory-style decision separate.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this record constrain interpretation. The enrollment is reported as 18, whereas the outcome summaries use 15.0 in each sequence group. The record does not explain the relationship between these figures, identify reasons for noncompletion, or describe missing-data handling. The stated primary population includes subjects who completed the study, so the available analysis may not represent all enrolled participants.

The study is unmasked, according to the registry record. For an objective laboratory concentration, lack of masking may be less directly relevant to measurement than for a subjective outcome, but the record does not describe laboratory procedures or safeguards. Participant and investigator masking details beyond the stated masking status are not reported.

The registry does not report the crossover analysis model, period or sequence handling, washout details, or within-participant covariance. As a result, the summary-statistic recalculation cannot be confirmed as reproducing the sponsor's intended comparison. The sponsor's ratio confidence limits and the equivalence margins are also absent, preventing assessment of the formal bioequivalence criterion.

The setting is limited to healthy subjects and fed administration of the specified 25 mg tablets. The record does not provide detailed participant characteristics or evidence about clinical outcomes. It reports only three secondary outcomes by name, although it lists six outcome measures and six analyses; details of the other measures are not reported in the registry record. Multiplicity procedures, the original sample-size rationale, and interim analyses are also not reported. These are limits of the registry entry and do not establish what may have appeared in other study documents.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Venlafaxine 25 mg Tablets Under Non-Fasting Conditions — NCT00834249.
• Registry record last updated 2024-08-19; status last verified 2024-08.
• Results first posted 2009-08-18.
• 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.

22. Record Summary

The registry record describes a completed Phase 1 randomized, unmasked, 2-way crossover study sponsored by Teva Pharmaceuticals USA. It compared venlafaxine 25 mg tablets with Effexor® 25 mg tablets under fed conditions in healthy subjects. Enrollment was 18; the reported primary analysis included completers, and the outcome summaries use 15.0 for each sequence group.

The primary endpoint was venlafaxine Cmax in plasma over a 24 hour sampling period. The sponsor reports a test/reference ratio of least-squares means multiplied by 100 of 101.73, without confidence limits or equivalence bounds in the registry record. An unadjusted recalculation gives a mean difference of -0.68 ng/mL, with an interval from -14.47 to 13.11 and p = 0.923. The available registry information describes the results but does not establish whether formal bioequivalence criteria were met.