EpilepsyPhase 1NCT02283840

Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation

A Phase 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: BIA 2-093
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: May 2007to Jun 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
Male or female aged of at least 18 years but not older than 55 years with a body mass index (BMI) greater than or equal to equal to 19 and below 30 kg/m2
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
Healthy according to the medical history, laboratory results and physical examination
Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An exsmoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study

Who cannot join

Significant history of hypersensitivity to eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
Presence of significant heart disease or disorder according to ECG
Presence or history of significant central nervous system disorder like convulsion or depression

Show all 19Show fewer

Participation in any previous study with eslicarbazepine acetate
Females who are pregnant according to a positive serum pregnancy test or are lactating
Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study
Use of systemic contraceptives (oral, implant, etc.) in the previous 14 days before day 1 of this study and until study completion.
Use of systemic contraceptives (injections) and hormonal replacement therapy in the previous 13 weeks before day 1 of this study and until study completion
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before Day 1 of this study
Participation in another clinical trial or donation of 50 mL or more of blood in the previous 28 days before day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4)
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive results to HIV, HBsAg or anti-HCV tests

About this study

Official title: Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate 400mg, 600mg and 800mg Tablets Clinical Trial Formulation (CTF) Versus the To-be-marketed Formulation (TBM) in Healthy Male and Female

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Read the detailed description

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design to evaluate and compare the relative bioavailability and therefore the bioequivalence of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations (CTF versus TBM) after a single oral dose administration under fasting conditions

Conditions: Epilepsy
Being tested: BIA 2-093
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIA 2-093Drug

Study groups in NCT02283840
Study group	Role	What they receive
Cohort A1:BIA 2-093 400 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) Receives: Drug: BIA 2-093
Cohort A2:BIA 2-093 400 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) Receives: Drug: BIA 2-093
Cohort B1:BIA 2-093 600 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) Receives: Drug: BIA 2-093
Cohort B2:BIA 2-093 600 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) Receives: Drug: BIA 2-093
Cohort C1:BIA 2-093 800 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) Receives: Drug: BIA 2-093
Cohort C2:BIA 2-093 800 mg	Experimental	One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) Receives: Drug: BIA 2-093

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005
Measured: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
Measured: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration
Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005
Measured: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jun 2007

First posted5 Nov 2014 (estimated)
Study startMay 2007
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02283840
Sponsor's protocol ID: BIA-2093-122
Status last verified: Dec 2014
First submitted: 3 Nov 2014
Last updated: 10 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
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Mapping of Human Cognition
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RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures
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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate 400mg, 600mg and 800mg Tablets Clinical Trial Formulation (CTF) Versus the To-be-marketed Formulation (TBM) in Healthy Male and Female
ClinicalTrials.gov ID: NCT02283840
Acronym / sponsor ID: BIA-2093-122
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 5 Nov 2014 (estimated)
Results: Posted 10 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
Cohort A1:BIA 2-093 400 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
Cohort A2:BIA 2-093 400 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)
Cohort B1:BIA 2-093 600 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
Cohort B2:BIA 2-093 600 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)
Cohort C1:BIA 2-093 800 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
Cohort C2:BIA 2-093 800 mg	Experimental	Drug: BIA 2-093One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
Male or female aged of at least 18 years but not older than 55 years with a body mass index (BMI) greater than or equal to equal to 19 and below 30 kg/m2
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
Healthy according to the medical history, laboratory results and physical examination
Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An exsmoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study

Key exclusion criteria (19 listed)

Significant history of hypersensitivity to eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
Presence of significant heart disease or disorder according to ECG

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIA 2-093	Drug	Cohort A1:BIA 2-093 400 mg, Cohort A2:BIA 2-093 400 mg, Cohort B1:BIA 2-093 600 mg, Cohort B2:BIA 2-093 600 mg, Cohort C1:BIA 2-093 800 mg, Cohort C2:BIA 2-093 800 mg

Primary outcome

Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005
Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration
Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005
Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration

Results and safety

Results posted to the registry on 10 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A:BIA 2-093 400 mg	20	20
Cohort B:BIA 2-093 600 mg	20	19
Cohort C:BIA 2-093 800 mg	20	20

Primary outcome: Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005

Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort A:BIA 2-093 400 mg n = 20	Cohort B:BIA 2-093 600 mg n = 19	Cohort C:BIA 2-093 800 mg n = 20
Cmax (BIA 2-005) Test	7107.7 (2004.4)	10724.8 (1941.2)	13186.4 (2307.6)
Cmax (BIA 2-005) Reference	6660.3 (1545.2)	10404.5 (1716.7)	12767.6 (2528.0)

Primary outcome: AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time

Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Cohort A:BIA 2-093 400 mg n = 20	Cohort B:BIA 2-093 600 mg n = 19	Cohort C:BIA 2-093 800 mg n = 20
AUC0-t (BIA 2-093) Test	125739.8 (29045.7)	219560.8 (39740.5)	294749.1 (48044.1)
AUC0-t (BIA 2-093) Reference	122134.1 (27602.3)	215750.4 (44444.6)	293959.9 (49385.3)

Primary outcome: Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005

Time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration. Median (Standard Deviation). Unit: hours

Measure	Cohort A:BIA 2-093 400 mg n = 20	Cohort B:BIA 2-093 600 mg n = 19	Cohort C:BIA 2-093 800 mg n = 20
Tmax (BIA 2-005) Test	2.00 (0.89)	2.50 (1.21)	3.00 (1.64)
Tmax (BIA 2-005) Reference	2.50 (1.24)	3.00 (1.30)	3.00 (1.31)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1	0 of 20 (0%)	8 of 20 (40%)	Not reported
Test 2	0 of 19 (0%)	8 of 19 (42.1%)	Not reported
Test 3	0 of 20 (0%)	8 of 20 (40%)	Not reported
Reference 1	0 of 20 (0%)	9 of 20 (45%)	Not reported
Reference 2	0 of 20 (0%)	6 of 20 (30%)	Not reported
Reference 3	0 of 20 (0%)	9 of 20 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Recruiting
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RecruitingPhase 2/3
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005 (time frame: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.