Trial · NCT02283827
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.
NCT02283827, Phase 1, Completed, Bial - Portela C S.A.; results first posted 2014-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin. Trials, record NCT02283827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02283827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.
- NCT number
- NCT02283827
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Bial - Portela C S.A.
- Conditions
- Epilepsy
- Interventions
- BIA 2-093, Phenytoin
- First posted
- 2014-11-05
- Last updated
- 2014-12-18
- Results first posted
- 2014-12-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax - the Maximum Plasma Concentration | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate |
| Secondary | AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate |
| Secondary | Tmax - the Time of Occurrence of Cmax | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax - the Maximum Plasma Concentration | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | ng/mL | MEAN | |
| SECONDARY | AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | ng*h/mL | MEAN | |
| SECONDARY | Tmax - the Time of Occurrence of Cmax | Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax - the Maximum Plasma Concentration | BIA 2-093 + Phenytoin | Cmax (BIA 2-194) | 16350.6 | Standard Deviation 2060.2 | ng/mL |
| Cmax - the Maximum Plasma Concentration | BIA 2-093 | Cmax (BIA 2-194) | 23806.5 | Standard Deviation 3047.2 | ng/mL |
| Cmax - the Maximum Plasma Concentration | BIA 2-093 + Phenytoin | Cmax (BIA 2-195) | 976.9 | Standard Deviation 194.4 | ng/mL |
| Cmax - the Maximum Plasma Concentration | BIA 2-093 | Cmax (BIA 2-195) | 954.3 | Standard Deviation 189.9 | ng/mL |
| Cmax - the Maximum Plasma Concentration | BIA 2-093 + Phenytoin | Cmax (PHT) | 12868.5 | Standard Deviation 6292.7 | ng/mL |
| Cmax - the Maximum Plasma Concentration | BIA 2-093 | Cmax (PHT) | 9405.1 | Standard Deviation 3621 | ng/mL |
| AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | BIA 2-093 + Phenytoin (PHT) | AUC0-t (BIA 2-194) | 251055.2 | Standard Deviation 34143.1 | ng*h/mL |
| AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | BIA 2-093 | AUC0-t (BIA 2-194) | 371574.9 | Standard Deviation 43474.3 | ng*h/mL |
| AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | BIA 2-093 + Phenytoin (PHT) | AUC0-t (BIA 2-195) | 19471.2 | Standard Deviation 4069.5 | ng*h/mL |
| AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time | BIA 2-093 | AUC0-t (BIA 2-195) | 20675.0 | Standard Deviation 4362.4 | ng*h/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A BIA 2-093 + Phenytoin (PHT) | 16 | |
| Overall Study | STARTED | Group B BIA 2-093 + Phenytoin (PHT) | 16 | |
| Overall Study | COMPLETED | Group A BIA 2-093 + Phenytoin (PHT) | 15 | |
| Overall Study | COMPLETED | Group B BIA 2-093 + Phenytoin (PHT) | 13 | |
| Overall Study | NOT COMPLETED | Group A BIA 2-093 + Phenytoin (PHT) | 1 | |
| Overall Study | NOT COMPLETED | Group B BIA 2-093 + Phenytoin (PHT) | 3 |
Source ClinicalTrials.gov
Adverse events511
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 | Abdominal distension | Gastrointestinal disorders | BIA 2-093 600 mg | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | BIA 2-093 1200 mg | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | BIA 2-093 1200 mg + Phenytoin 100 mg | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | BIA 2-093 1200 mg + Phenytoin 300 mg | 2 | 32 | |
| other | Abdominal distension | Gastrointestinal disorders | Phenytoin 100 mg | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | Phenytoin 300 mg | 0 | 16 | |
| other | Abdominal distension | Gastrointestinal disorders | BIA 2-093 600 mg + Phenytoin 300 mg | 0 | 16 | |
| other | Ear pain | Ear and labyrinth disorders | BIA 2-093 600 mg | 0 | 16 | |
| other | Ear pain | Ear and labyrinth disorders | BIA 2-093 1200 mg | 0 | 16 | |
| other | Ear pain | Ear and labyrinth disorders | BIA 2-093 1200 mg + Phenytoin 100 mg | 0 | 16 |
1 to 10 of 511Source ClinicalTrials.gov
See all 511 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BIA 2-093 600 mg | ||
| Total, all-cause mortality | BIA 2-093 1200 mg | ||
| Total, all-cause mortality | BIA 2-093 1200 mg + Phenytoin 100 mg | ||
| Total, all-cause mortality | BIA 2-093 1200 mg + Phenytoin 300 mg | ||
| Total, all-cause mortality | Phenytoin 100 mg | ||
| Total, all-cause mortality | Phenytoin 300 mg | ||
| Total, all-cause mortality | BIA 2-093 600 mg + Phenytoin 300 mg | ||
| Total, other adverse events | BIA 2-093 600 mg | 3 | 16 |
| Total, other adverse events | BIA 2-093 1200 mg | 12 | 16 |
| Total, other adverse events | BIA 2-093 1200 mg + Phenytoin 100 mg | 7 | 16 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02283827
GET https://conductscience.org/api/trials/v1/NCT02283827/events?page=2