Trial · NCT01355068
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
NCT01355068, Phase 1, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-12-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia. Trials, record NCT01355068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01355068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
- NCT number
- NCT01355068
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Healthy
- Interventions
- Epanutin Infatabs (Phenytoin), Dilantin Infatabs (Phenytoin)
- First posted
- 2011-05-17
- Last updated
- 2021-01-28
- Results first posted
- 2011-12-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose | Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast). |
| Primary | Maximum Observed Plasma Concentration (Cmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). |
| Secondary | Extrapolated Area Under the Curve (AUC Percent [%] Extrap) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | AUC%extrap is the percentage of AUC \[0-∞\] obtained by forward extrapolation. It is calculated as (AUC \[0-∞\] minus AUClast)\*100/ AUC \[0-∞\], where AUC \[0-∞\] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. |
| Secondary | Plasma Decay Half Life (t1/2) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose | Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Extrapolated Area Under the Curve (AUC Percent [%] Extrap) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Percent AUC | GEOMETRIC_MEAN |
| SECONDARY | Plasma Decay Half Life (t1/2) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | hr | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | hr | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Epanutin Infatabs 50 mg | 21380.0 | Standard Deviation 6043.0 | ng*hr/mL | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Dilantin Infatabs 50 mg | 21370.0 | Standard Deviation 5571.2 | ng*hr/mL | |
| Maximum Observed Plasma Concentration (Cmax) | Epanutin Infatabs 50 mg | 952.10 | Standard Deviation 229.25 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) | Dilantin Infatabs 50 mg | 976.50 | Standard Deviation 214.78 | ng/mL | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) | Epanutin Infatabs 50 mg | 21730.0 | Standard Deviation 6345.9 | ng*hr/mL | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) | Dilantin Infatabs 50 mg | 21740.0 | Standard Deviation 5816.7 | ng*hr/mL | |
| Extrapolated Area Under the Curve (AUC Percent [%] Extrap) | Epanutin Infatabs 50 mg | 3.321 | Standard Deviation 4.884 | Percent AUC | |
| Extrapolated Area Under the Curve (AUC Percent [%] Extrap) | Dilantin Infatabs 50 mg | 3.198 | Standard Deviation 4.805 | Percent AUC | |
| Plasma Decay Half Life (t1/2) | Epanutin Infatabs 50 mg | 14.380 | Standard Deviation 3.247 | hr | |
| Plasma Decay Half Life (t1/2) | Dilantin Infatabs 50 mg | 14.970 | Standard Deviation 4.777 | hr |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period | STARTED | Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg | 13 | |
| First Intervention Period | STARTED | Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg | 13 | |
| First Intervention Period | COMPLETED | Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg | 13 | |
| First Intervention Period | COMPLETED | Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg | 11 | |
| First Intervention Period | NOT COMPLETED | Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg | 0 | |
| First Intervention Period | NOT COMPLETED | Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg | 2 | |
| Washout Period (at Least 7 Days) | STARTED | Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg | 13 | |
| Washout Period (at Least 7 Days) | STARTED | Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg | 11 | |
| Washout Period (at Least 7 Days) | COMPLETED | Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg | 13 | |
| Washout Period (at Least 7 Days) | COMPLETED | Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Epanutin Infatabs 50 mg | 1 | 24 | |
| other | Upper respiratory tract infection | Infections and infestations | Dilantin Infatabs 50 mg | 1 | 26 | |
| other | Dizziness | Nervous system disorders | Epanutin Infatabs 50 mg | 1 | 24 | |
| other | Dizziness | Nervous system disorders | Dilantin Infatabs 50 mg | 0 | 26 | |
| other | Headache | Nervous system disorders | Epanutin Infatabs 50 mg | 2 | 24 | |
| other | Headache | Nervous system disorders | Dilantin Infatabs 50 mg | 0 | 26 | |
| other | Rash | Skin and subcutaneous tissue disorders | Epanutin Infatabs 50 mg | 0 | 24 | |
| other | Rash | Skin and subcutaneous tissue disorders | Dilantin Infatabs 50 mg | 1 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epanutin Infatabs 50 mg | ||
| Total, all-cause mortality | Dilantin Infatabs 50 mg | ||
| Total, other adverse events | Epanutin Infatabs 50 mg | 4 | 24 |
| Total, other adverse events | Dilantin Infatabs 50 mg | 2 | 26 |
| Total, serious adverse events | Epanutin Infatabs 50 mg | 0 | 24 |
| Total, serious adverse events | Dilantin Infatabs 50 mg | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Epanutin Infatabs 50 mg vs Dilantin Infatabs 50 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01355068
GET https://conductscience.org/api/trials/v1/NCT01355068/registered