This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers (NCT02767128), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02767128 |
| Phase | Phase 1 |
| Condition | Iron-refractory, Iron-deficiency Anemia (IRIDA) |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 14 |
| Arms in the primary outcome | 6 |
| Lead sponsor | Rockwell Medical Technologies, Inc. |
| Results posted | Yes |
2. Clinical Question
The study asked how total-iron concentrations changed after different single-dose iron regimens in healthy adult volunteers. Its main focus was the maximum observed concentration, or Cmax, after oral Triferic, with comparisons across the other treatment conditions described in the registry record. The participants were healthy volunteers; although iron-refractory, iron-deficiency anemia is listed as a condition, the record does not describe an anemia patient population.
Population
Healthy adult volunteers participated in a randomized, multiple-treatment study. The record reports that 14 patients completed all six treatments. It does not provide further demographic details in the posted results.
Intervention
The oral conditions included Fer-In-Sol and Triferic, each at 3 mg iron/kg, both alone and with Shohl's solution given before the iron dose. Shohl's solution was given either 10 minutes before or immediately before Triferic in the relevant conditions. An intravenous Triferic condition used 6.6 mg infused over 4 hours. A baseline iron profile was also described, without study drug.
Comparator
The registry describes multiple treatment conditions rather than a single control comparison. Fer-In-Sol alone is Treatment A; the other conditions include Fer-In-Sol with Shohl's solution, oral Triferic regimens, and intravenous Triferic. Baseline assessment is described separately.
Primary question
The primary endpoint was the geometric mean Cmax of total iron, measured in microgram/deciliter, across the treatment conditions. Samples were scheduled at 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours. The registry record does not report a formal statistical comparison or an estimate of the difference between treatments.
The randomized crossover structure means the study was designed around repeated treatment conditions rather than independent parallel groups. The registry says that participants completed all six treatments, but details such as treatment sequence and washout are not reported in the registry record. The posted findings therefore describe pharmacokinetic measurements from this healthy-volunteer study, not clinical outcomes in people being treated for anemia.
3. Trial Design
This was a Phase 1, randomized, unmasked crossover study with an enrollment of 14. Its stated purpose was to determine the pharmacokinetics of orally administered Triferic in healthy adult volunteers. The brief summary describes a multiple-treatment, single-dose study. The study status is completed; the start and primary completion are both recorded as 2016-04.
The treatment conditions comprised six regimens. Treatment A was a single oral dose of Fer-In-Sol at 3 mg iron/kg body weight. Treatment B paired the same Fer-In-Sol dose with Shohl's solution given 10 minutes beforehand. Treatment C was oral Triferic at 3 mg iron/kg. Treatment D was the same oral Triferic dose after Shohl's solution given 10 minutes beforehand, while Treatment E used Shohl's solution immediately before oral Triferic. Treatment F was Triferic given intravenously as 6.6 mg in a 120 mL infusion over 4 hours. The registry also describes a baseline serum iron profile without study drug.
The primary outcome was total-iron Cmax, assessed across the treatment conditions at scheduled times from 0 through 24 hours. The record reports that 14 patients completed all six treatments, while the analysis counts for the Cmax results vary by condition. It notes that some collected samples were below the assay's quantifiable limit. The number of participants analyzed for each condition is reported with the corresponding result, but the registry's description of the analysis population is truncated.
Randomization and crossover are features of the design, but the registry does not report the randomization sequence, the interval between treatment periods, or a washout procedure. Masking was none. The record does not report a protocol rationale for the enrollment, a planned sample-size justification, or a prespecified statistical analysis plan. These omissions limit what can be concluded about the design details beyond those explicitly recorded.
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.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 14 |
| Baseline | 14 |
| Fer-In-Sol | 14 |
| Shohl's + Fer-In-Sol | 14 |
| Triferic | 14 |
| Shohl's + Triferic After 10 Min | 14 |
| Shohl's + Triferic Immediately | 14 |
| COMPLETED | 14 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: 14 patients completed all six treatments. While all participants had adequate blood samples collected to be included in pharmacokinetic analysis, some samples were below the quantifiable limit (BLQ) of the bioanalytical assay, which was 50 micrograms/deciliter. Therefore, number of participants analyzed for each treatment does not equal 14.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Safety Population |
|---|---|---|
| Participants analysed | 14 | |
| Age, Continuous | years | 39.1 (SD 11.99) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 12 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 14 |
| Body Mass Index | Kilogram/square meter | 24.5 (SD 3.93) |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax, measured over 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | microgram/deciliter |
| Endpoint classification | not reduced to a single comparison |
Cmax is the maximum concentration observed after a dose. For this study, the endpoint was the geometric mean of total iron concentration, expressed in microgram/deciliter, across the stated treatment conditions. Concentrations were scheduled at 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours. Measuring concentration over time can describe the peak exposure recorded within the sampling schedule; it does not by itself establish a clinical benefit or characterize every aspect of exposure.
The registry reports geometric coefficients of variation alongside the geometric means. General explanation: a geometric mean is commonly used for measurements that are analyzed on a multiplicative scale or that have a skewed distribution. A geometric coefficient of variation describes relative dispersion on that scale. It is not a confidence interval and does not directly show how precisely a treatment contrast is estimated.
The posted outcome is total iron, rather than a clinical endpoint. It is therefore a pharmacokinetic measure: it describes measured concentrations following the treatment conditions. Cmax is useful for describing the observed peak within the sampling schedule, while other pharmacokinetic questions would require other measures. The registry record does not report those other measures as primary outcomes.
The assay's quantifiable limit was 50 micrograms/deciliter, and the record notes that some samples were below that limit. This matters because a value below the quantifiable limit cannot be treated as an ordinary measured concentration without a stated handling rule. The registry record does not report the method used to handle those values in the Cmax calculation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted Cmax results are descriptive geometric means with geometric coefficients of variation. For Treatment A, Fer-In-Sol alone, the geometric mean was 140 microgram/deciliter, with a geometric coefficient of variation of 39.4, based on 14 participants. For Treatment B, Shohl's solution followed by Fer-In-Sol, the corresponding figures were 62 and 78.7, based on 13 participants. For Treatment C, oral Triferic alone, they were 32.4 and 93.9, based on 7 participants. Treatment D, Shohl's solution followed by Triferic after 10 minutes, had a geometric mean of 51.9 and a geometric coefficient of variation of 82.2, based on 11 participants. Treatment E, Shohl's solution followed immediately by Triferic, had values of 52.0 and 71.8, based on 10 participants. Treatment F, intravenous Triferic, had values of 100 and 91.5, based on 13 participants.
These results describe the recorded concentrations for the participants included in each condition's analysis. They are not estimates of treatment differences. The registry record contains no posted pairwise contrasts, confidence intervals for contrasts, or significance tests for the primary endpoint. The numerical ordering of the geometric means should therefore not be read as evidence that one condition differs statistically from another. No new differences or ratios are calculated from the reported means.
The geometric coefficients of variation are substantial for several conditions, indicating considerable relative variability in the analyzed concentration measurements on the geometric scale. General explanation: variability describes how spread out measurements are; it is distinct from uncertainty about a treatment contrast. Without a reported contrast and its uncertainty, the precision of a between-treatment conclusion cannot be assessed from the arm-level summaries alone.
Analysis counts range from 7 to 14 across the conditions. The registry says all participants had adequate blood samples collected for pharmacokinetic analysis, but some samples were below the assay's quantifiable limit of 50 micrograms/deciliter. It also states that this affected the number of participants included in the pharmacokinetic analysis. The record does not fully specify how below-limit observations were handled or why the analysis count differs for each condition. The observed means consequently describe the analysis sets recorded for each treatment, and not necessarily a common set of participants across all conditions.
Safety reporting is separate from the pharmacokinetic endpoint. No treatment-emergent serious adverse events or deaths are reported in any treatment group. The counts of participants with other treatment-emergent adverse events vary by group. These are descriptive counts; the record does not provide a comparative safety analysis. Neither the pharmacokinetic summaries nor the adverse-event counts establish clinical effectiveness or comparative safety.
9. Statistical Methods Explained
The statistical information in the registry record is limited to descriptive pharmacokinetic summaries and adverse-event counts. No statistical analyses are posted for the primary endpoint, and the record does not report a formal model, treatment contrast, confidence interval, or hypothesis test. The explanations below distinguish what those summaries mean from what a fuller analysis could address.
What does the geometric mean describe?
The primary endpoint is reported as a geometric mean. General explanation: when measurements are analyzed on a multiplicative scale, values are often transformed to a logarithmic scale, summarized there, and transformed back. This can be appropriate for positive concentration measurements whose variation is better understood proportionally than as a fixed absolute amount. The geometric mean is not the same as the arithmetic average, and its meaning should be interpreted together with the scale and analysis method. The registry record names the summary but does not report the calculation procedure or any model used to derive it.
The listed geometric coefficient of variation describes relative spread among measurements on a geometric scale. It is not a measure of the uncertainty of a treatment effect, and it does not substitute for a confidence interval around a contrast. A wide spread can make treatment comparisons less precise, but the exact precision cannot be established from these summaries alone.
Why does sampling time matter for Cmax?
Cmax is the maximum concentration recorded among the scheduled measurements. In this study, collection times were 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours. General explanation: a measured maximum depends on the sampling schedule. A peak between scheduled samples may not be directly observed, so the endpoint represents the maximum captured by the planned measurements rather than a continuously observed maximum. The registry record does not report additional sampling details or a procedure for estimating an unobserved peak.
The endpoint concerns total iron concentrations. Its interpretation is therefore pharmacokinetic and depends on the timing and quality of measurements, the assay, and the handling of values outside the quantifiable range. It does not directly measure a clinical outcome.
How should the crossover design be understood?
In a crossover design, participants receive more than one treatment condition, allowing observations from different conditions to be collected within the same participants. General explanation: when the analysis appropriately accounts for repeated observations, within-participant comparisons can separate treatment differences from some sources of variation between people. That potential advantage depends on the design and analysis details. The registry confirms randomization and a crossover model, and reports that 14 patients completed all six treatments. It does not report the treatment sequences, period effects, washout arrangements, or a statistical model accounting for repeated measurements. It is not possible to confirm from the record how these features were handled analytically.
The posted analysis counts differ by treatment condition. The available summaries do not show whether the same participants contributed to every condition's estimate. A direct within-participant comparison would need to account for which observations are paired, and the registry does not provide those comparison results.
What does the below-limit information imply?
The bioanalytical assay's stated quantifiable limit was 50 micrograms/deciliter. The record reports that some samples were below this limit and that this affected the number of participants included in pharmacokinetic analyses. General explanation: a below-limit value is not equivalent to a reliably quantified concentration. Analysis choices can include excluding some observations or applying a specified method for handling them, but the choice can affect estimates. The registry record does not report the handling rule, the number of below-limit samples, or the reasons for the analysis count in each treatment condition. No imputation or other handling method should be assumed.
What can be concluded without contrasts?
A treatment contrast estimates the difference or ratio between specified conditions, depending on the analysis scale. A confidence interval communicates the uncertainty around that estimate, while a hypothesis test evaluates a specified null hypothesis under stated assumptions. General explanation: both depend on the analysis model and the data used. The registry record posts arm-level geometric means and coefficients of variation, but not treatment contrasts, confidence intervals, or p-values. Thus, the reported summaries cannot establish whether apparent differences between treatment means exceed sampling uncertainty.
The record reports no posted analyses. It does not state whether unreported analyses were conducted elsewhere, so the absence of registry analyses should be read as absence of results in the registry record, not as proof that no analysis was performed. A protocol-level statistical plan, including model specification and multiplicity handling, is not reported in the registry record.
How should planning illustrations be read?
The planning assumptions describe illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. General explanation: such calculations explore the sample size that might be needed under specified assumptions. They are not the study's observed power, do not establish the power of this completed crossover study, and are not evidence of an actual treatment effect. The registry record does not report the trial's own sample-size justification. The illustrations also do not replace a prespecified plan tailored to this crossover design and its repeated measurements.
10. Multiplicity, Missing Data and Analysis Populations
The study contains multiple treatment conditions and reports a primary pharmacokinetic outcome along with two secondary outcomes: the number of participants with treatment-emergent adverse events and the number with treatment-emergent serious adverse events. Comparing several treatment conditions can raise multiplicity concerns because the chance of at least one false-positive finding can increase when multiple hypotheses are tested. General explanation: a prespecified testing strategy may control that risk, or analyses may be presented as descriptive. The registry record does not report a multiplicity adjustment or a hierarchy of tests. Since no statistical analyses are posted, there are no reported primary-endpoint tests to interpret as adjusted or unadjusted.
The Cmax analysis counts vary by condition, and the registry explains that some samples were below the assay's quantifiable limit of 50 micrograms/deciliter. The number of participants analyzed for each condition is not fully explained in the truncated population description. The record does not report the number of below-limit samples, their distribution by treatment, or how they were handled. It also does not report whether missing or excluded measurements occurred for other reasons. These details matter because analysis populations may differ between conditions, complicating direct comparisons.
The record says 14 patients completed all six treatments and that all participants had adequate blood samples collected to be included in pharmacokinetic analysis, while some samples were below the quantifiable limit. The wording does not establish that every participant contributed a usable Cmax value to every condition. No intention-to-treat or per-protocol analysis population is defined in the registry record, and no sensitivity analysis for below-limit or missing observations is reported.
The crossover design creates repeated measurements within participants. General explanation: analyses typically need to account for that dependence rather than treat all measurements as independent. The registry record does not report a model, sequence or period terms, or handling of incomplete treatment data. The record also does not report an interim-analysis plan, a detailed statistical analysis plan, or the trial's sample-size justification.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fer-In-Sol Orally | 0 | 14 | 0.0% |
| Shohl's Solution Followed by Fer-In-Sol Orally | 0 | 14 | 0.0% |
| Triferic Orally | 0 | 14 | 0.0% |
| Shohl's Solution Followed by Triferic Orally | 0 | 14 | 0.0% |
| Shohl's Solution Followed Immediately by Triferic | 0 | 14 | 0.0% |
| Triferic Via IV | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fer-In-Sol Orally | 0 of 14 |
| Shohl's Solution Followed by Fer-In-Sol Orally | 0 of 14 |
| Triferic Orally | 0 of 14 |
| Shohl's Solution Followed by Triferic Orally | 0 of 14 |
| Shohl's Solution Followed Immediately by Triferic | 0 of 14 |
| Triferic Via IV | 0 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fer-In-Sol Orally | 7 of 14 |
| Shohl's Solution Followed by Fer-In-Sol Orally | 5 of 14 |
| Triferic Orally | 2 of 14 |
| Shohl's Solution Followed by Triferic Orally | 6 of 14 |
| Shohl's Solution Followed Immediately by Triferic | 6 of 14 |
| Triferic Via IV | 2 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fer-In-Sol Orally | Shohl's Solution Followed by Fer-In-Sol Orally | Triferic Orally | Shohl's Solution Followed by Triferic Orally | Shohl's Solution Followed Immediately by Triferic | Triferic Via IV |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 6 of 14 | 1 of 14 | 1 of 14 | 3 of 14 | 2 of 14 | 0 of 14 |
| Abdominal Pain | Gastrointestinal disorders | 3 of 14 | 1 of 14 | 0 of 14 | 2 of 14 | 1 of 14 | 0 of 14 |
| Diarrhoea | Gastrointestinal disorders | 1 of 14 | 2 of 14 | 0 of 14 | 2 of 14 | 1 of 14 | 0 of 14 |
| Abdominal Discomfort | Gastrointestinal disorders | 2 of 14 | 0 of 14 | 0 of 14 | 1 of 14 | 1 of 14 | 0 of 14 |
| Defaecation Urgency | Gastrointestinal disorders | 1 of 14 | 0 of 14 | 0 of 14 | 1 of 14 | 1 of 14 | 0 of 14 |
| Flatuence | Gastrointestinal disorders | 0 of 14 | 2 of 14 | 0 of 14 | 1 of 14 | 0 of 14 | 0 of 14 |
| Abdominal Distension | Gastrointestinal disorders | 0 of 14 | 0 of 14 | 0 of 14 | 1 of 14 | 1 of 14 | 0 of 14 |
| Abdominal Pain Lower | Gastrointestinal disorders | 0 of 14 | 0 of 14 | 0 of 14 | 1 of 14 | 0 of 14 | 0 of 14 |
| Abdominal Pain Upper | Gastrointestinal disorders | 0 of 14 | 0 of 14 | 0 of 14 | 0 of 14 | 1 of 14 | 0 of 14 |
| Vomiting | Gastrointestinal disorders | 0 of 14 | 1 of 14 | 0 of 14 | 0 of 14 | 0 of 14 | 0 of 14 |
The serious adverse-event outcome is reported as the number of participants with treatment-emergent serious adverse events. The registry lists 0 affected participants among 14 at risk in each of the six treatment groups. It also reports 0 deaths in every group. No serious adverse-event terms are listed.
These are participant counts, not estimates of comparative risk. The record does not report statistical comparisons or confidence intervals for safety outcomes. General explanation: observing no affected participants in a study does not establish that the underlying risk is zero; the precision of a safety estimate depends on the amount and duration of observation, as well as the study population. The registry record does not provide enough information to quantify that uncertainty.
Other treatment-emergent adverse events are reported separately. The number of participants affected was 7 with Fer-In-Sol orally, 5 with Shohl's solution followed by Fer-In-Sol, 2 with oral Triferic, 6 with Shohl's solution followed by Triferic after 10 minutes, 6 with Shohl's solution followed immediately by Triferic, and 2 with intravenous Triferic. These counts do not indicate severity or establish that a treatment caused an event. Because the study used a crossover design, the group counts should not be added to infer a number of unique participants.
The registry record does not provide event-level descriptions for the non-serious events in these summaries, nor does it report comparative safety analyses. The serious-event counts should be read as the reported observations for this study, not as a general estimate for other populations or settings.
12. What the Result Does, and Does Not, Mean
The posted results give a descriptive account of total-iron Cmax across six treatment conditions in a randomized crossover study of healthy adult volunteers. The geometric means range across the reported values, and the accompanying geometric coefficients of variation show that the measurements varied on the geometric scale. The analysis count is not the same for every condition. These findings describe the pharmacokinetic measurements available for each treatment analysis; they are not, on their own, evidence of a statistically established treatment difference.
The record does not report treatment contrasts, confidence intervals, p-values, or a statistical model for the primary endpoint. It is therefore not possible to determine from the registry results whether any difference between conditions is distinguishable from sampling variation. A comparison based only on the ordering of arm-level means would ignore the uncertainty in those estimates and the repeated-measures nature of a crossover study.
The assay's quantifiable limit and the presence of below-limit samples are important to interpretation. The record reports that these samples affected the number of participants included in pharmacokinetic analyses, but it does not provide the handling method or full analysis-population details. The estimated means may consequently represent different analysis sets across conditions, and the registry record does not allow assessment of how that affected the results.
These findings do not establish how the treatment conditions affect iron status or health outcomes in people with anemia. Participants were healthy volunteers, the primary outcome was a concentration measure, and no clinical efficacy outcome is reported. The study also does not establish comparative safety: serious adverse-event and death counts were zero in the groups, while other adverse-event counts were reported descriptively without comparative analysis.
The registry record is useful for identifying the studied regimens, the concentration endpoint, and the observed summaries. It does not provide enough statistical detail to support an inferential conclusion about one regimen relative to another. The planning illustrations are assumptions-based calculations, not observed power and not evidence that the study demonstrated an effect.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it combines a randomized crossover design with several distinct dosing conditions. A crossover study can collect repeated measurements within participants, which may support comparisons that account for participant-to-participant variation. That design feature is most useful when the treatment sequence, timing between conditions, and analysis of repeated observations are clearly described. The registry confirms the crossover model and randomization, but those further details are not reported in the registry record.
The primary outcome is a pharmacokinetic peak concentration rather than a clinical endpoint. That distinction matters: an observed concentration summary answers a question about measured exposure under the study conditions, but it does not answer whether a treatment changes a health outcome. The schedule of samples also defines what is meant by the observed maximum, because a peak can only be captured at a scheduled measurement.
The below-limit samples make the analysis population important. Although 14 patients completed all six treatments, the Cmax analysis counts vary across conditions. The record notes that some samples fell below the assay's quantifiable limit, but does not report the handling method or all reasons for the different counts. A reader therefore cannot evaluate whether the estimates are directly comparable as paired summaries.
Finally, the registry record illustrates why descriptive estimates, variability measures, inferential comparisons, and safety counts should be distinguished. Geometric means and coefficients of variation characterize the posted concentration summaries; they do not provide a treatment contrast or its uncertainty. Likewise, zero reported serious adverse events is a study observation, not proof of zero risk. Clear reporting of the model, analysis populations, missing-data handling, and multiplicity strategy would be needed to support stronger statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this study affect interpretation. The registry describes healthy adult volunteers, whereas iron-refractory, iron-deficiency anemia appears in the condition listing. The record does not describe participants with that condition as the study population, so the results should be understood as coming from healthy volunteers. No demographic characteristics or other eligibility details are reported in the posted results.
The study included multiple treatment conditions and the primary outcome was a concentration measure. The record provides no treatment contrasts, confidence intervals, p-values, or statistical model. It is not possible to assess the uncertainty around differences between regimens or to verify how repeated observations were handled. The randomization sequence, treatment period details, and washout arrangements are not reported in the registry record.
Analysis counts range from 7 to 14 across conditions. The registry attributes limitations in pharmacokinetic analysis to samples below the quantifiable limit of 50 micrograms/deciliter, but the handling method and the number of affected samples are not reported. The primary population description is truncated, and the record does not explain all condition-specific analysis counts. This leaves uncertainty about the comparability of the analysis sets.
The record does not report the planned sample-size justification, a detailed statistical analysis plan, multiplicity handling, or interim analyses. Its planning assumptions are illustrations based on an observed effect and should not be mistaken for the original design rationale or observed power. Safety reporting is also limited to participant counts; there are no reported comparative analyses, and no serious-event terms are listed. These omissions restrict both statistical and clinical interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers — NCT02767128.
- Registry record last updated 2019-02-01; status last verified 2018-08.
- Results first posted 2019-02-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed Phase 1 study was randomized, unmasked, and used a crossover design. It enrolled 14 healthy adult volunteers and examined single-dose Fer-In-Sol and Triferic regimens, including conditions with Shohl's solution and an intravenous Triferic condition. The registry states that 14 patients completed all six treatments.
The primary outcome was geometric mean total-iron Cmax in microgram/deciliter, with a geometric coefficient of variation, measured at 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours. Analysis counts differed across conditions; the record notes that some samples were below the assay's quantifiable limit of 50 micrograms/deciliter. No inferential analyses or treatment contrasts are posted.
No treatment-emergent serious adverse events or deaths were reported in the treatment groups. Other adverse-event participant counts were reported descriptively. The registry record does not report the statistical analysis plan, handling of below-limit samples, or detailed crossover procedures.