EpilepsyPhase 1NCT02284880

Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate

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

Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) 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: 40 participants
Where: No sites listed yet
Study dates: Oct 2010to Nov 2010
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

A signed and dated informed consent form before any study-specific screening procedure was performed,
Healthy male or female 18 to 55 of age, inclusive,
Had a BMI within the range of 18 to 25 kg/m2 inclusive at screening,
Had a physical examination, vital signs, electrocardiogram (ECG) and routine laboratory tests within normal ranges or considered as non clinically significant (NCS) by the Investigator,
Non-smokers or smokers of less than 10 cigarettes per day,
If female, she was not of childbearing potential by reason of surgery (hysterectomy, bilateral oophorectomy or tubal ligation) or, if of childbearing potential, she had to be using one of the following effective method of contraception (intrauterine device (IUD) or abstention or condom) for the duration of the trial and had to have a negative urine pregnancy test at screening visit and upon each admission period.

Who cannot join

Had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue disease or disorders, or have a clinically relevant surgical history,
Presented any disease or condition (medical or surgical) which, in the opinion of the Investigator, that may have interfered with the absorption, distribution, metabolism or excretion of study drug,
Had a history of relevant atopy or any drug hypersensitivity (including known hypersensitivity to eslicarbazepine acetate or any of its excipients),
Had a history of alcoholism or drug abuse within 1 year before D 1,
Consumption of more than 50 g of ethanol per day (12.5 Centiliters [cL] glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g),
Use of medicines within 2 weeks of admission to first treatment period that could affect, in the Investigator's opinion, the safety of the subject,

Show all 11Show fewer

Had used any investigational drug or participated in any clinical trial within 2 months of admission to first treatment period,
Had donated or received any blood or blood products within 2 months prior to screening,
Could not communicate reliably with the investigator, was unlikely to co-operate with the requirements of the study,
Was unwilling or unable to give written informed consent,
If female, was pregnant or breast-feeding,

About this study

Official title: Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects

Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)

Read the detailed description

Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API) sources [current API source - marketed formulation (MF) versus new API source - to-be-marketed (TBM)] of eslicarbazepine acetate (ESL)

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
Also called ESL, Eslicarbazepine acetate
MF - Marketed formulation
BIA 2-093Drug
Also called ESL, Eslicarbazepine acetate
TBM - to-be-marketed

Study groups in NCT02284880
Study group	Role	What they receive
Group 1 BIA 2-093	Experimental	Subjects randomly received on period 1 and 2, either a single 400 mg tablet of ESL (MF - marketed formulation), or a single 400 mg tablet of ESL (TBM - o-be-marketed); Receives: Drug: BIA 2-093
Group 2 BIA 2-093	Experimental	Subjects randomly received on period 1 and 2, either a single 800 mg tablet of ESL (MF - marketed formulation), or a single 800 mg dose of ESL (TBM - o-be-marketed). Receives: Drug: BIA 2-093

What is being measured

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

Cmax - Maximum Plasma Concentration
Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Measured: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
Tmax - Time of Occurrence of Cmax
Reference - MF - marketed formulation Test - TBM - to-be-marketed
BIA 2-005 - BIA 2-093 metabolite
Measured: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
Reference - MF - marketed formulation Test - TBM - to-be-marketed
BIA 2-005 - BIA 2-093 metabolite
Measured: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period

Timeline

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

Oct 2010Nov 2010

First posted6 Nov 2014 (estimated)
Study startOct 2010
Primary completionNov 2010
Study completionNov 2010

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284880
Sponsor's protocol ID: BIA-2093-130
Status last verified: Jan 2015
First submitted: 4 Nov 2014
Last updated: 12 Jan 2015
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

Not yet recruiting
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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate in Healthy Subjects
ClinicalTrials.gov ID: NCT02284880
Acronym / sponsor ID: BIA-2093-130
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 6 Nov 2014 (estimated)
Results: Posted 12 Jan 2015

Clinical summary

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

Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)

Detailed description

Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API) sources [current API source - marketed formulation (MF) versus new API source - to-be-marketed (TBM)] of eslicarbazepine acetate (ESL)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Group 1 BIA 2-093	Experimental	Drug: BIA 2-093Subjects randomly received on period 1 and 2, either a single 400 mg tablet of ESL (MF - marketed formulation), or a single 400 mg tablet of ESL (TBM - o-be-marketed);
Group 2 BIA 2-093	Experimental	Drug: BIA 2-093Subjects randomly received on period 1 and 2, either a single 800 mg tablet of ESL (MF - marketed formulation), or a single 800 mg dose of ESL (TBM - o-be-marketed).

Who may qualify

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

Key inclusion criteria (6 listed)

A signed and dated informed consent form before any study-specific screening procedure was performed,
Healthy male or female 18 to 55 of age, inclusive,
Had a BMI within the range of 18 to 25 kg/m2 inclusive at screening,
Had a physical examination, vital signs, electrocardiogram (ECG) and routine laboratory tests within normal ranges or considered as non clinically significant (NCS) by the Investigator,
Non-smokers or smokers of less than 10 cigarettes per day,

Key exclusion criteria (11 listed)

Had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue disease or disorders, or have a clinically relevant surgical history,
Presented any disease or condition (medical or surgical) which, in the opinion of the Investigator, that may have interfered with the absorption, distribution, metabolism or excretion of study drug,
Had a history of relevant atopy or any drug hypersensitivity (including known hypersensitivity to eslicarbazepine acetate or any of its excipients),
Had a history of alcoholism or drug abuse within 1 year before D 1,
Consumption of more than 50 g of ethanol per day (12.5 Centiliters [cL] glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g),

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 2-093Also: ESL, Eslicarbazepine acetateMF - Marketed formulation	Drug	Group 1 BIA 2-093, Group 2 BIA 2-093
BIA 2-093Also: ESL, Eslicarbazepine acetateTBM - to-be-marketed	Drug	Group 1 BIA 2-093, Group 2 BIA 2-093

Primary outcome

Cmax - Maximum Plasma Concentration
Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Tmax - Time of Occurrence of Cmax
Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite

Results and safety

Results posted to the registry on 12 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
400 mg BIA 2-093 Group 1	11	11
400 mg BIA 2-093 Group 2	9	9
800 mg BIA 2-093 Group 1	10	8
800 mg BIA 2-093 Group 2	10	10

Primary outcome: Cmax - Maximum Plasma Concentration

Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period. Mean (Standard Deviation). Unit: ng/ml

Measure	400 mg BIA 2-093 n = 20	800 mg BIA 2-093 n = 18
Cmax (BIA 2-005 Reference)	6461 (1346)	13183 (2564)
Cmax (BIA 2-005 Test)	6547 (1524)	12988 (2215)

Primary outcome: Tmax - Time of Occurrence of Cmax

Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period. Median (Full Range). Unit: hours

Measure	400 mg BIA 2-093 n = 20	800 mg BIA 2-093 n = 18
Tmax (BIA 2-005 Reference)	2.00 (0.50 to 6.00)	2.00 (1.00 to 4.02)
Tmax (BIA 2-005 Test)	2.00 (0.50 to 6.00)	1.75 (1.00 to 6.00)

Primary outcome: AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification

Time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period. Mean (Standard Deviation). Unit: ng.hr/ml

Measure	400 mg BIA 2-093 n = 20	800 mg BIA 2-093 n = 18
AUC0-t (BIA 2-005 Reference)	112568 (23011)	279035 (60183)
AUC0-t (BIA 2-005 Test)	108224 (23971)	278734 (61738)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Before Treatment	0 of 40 (0%)	1 of 40 (2.5%)	Not reported
400 mg Tablet of ESL (MF)	0 of 20 (0%)	0 of 20 (0%)	Not reported
400 mg Tablet of ESL (TBM)	0 of 20 (0%)	1 of 20 (5%)	Not reported
800 mg Tablet of ESL (MF)	0 of 20 (0%)	4 of 20 (20%)	Not reported
800 mg Tablet of ESL (TBM)	0 of 18 (0%)	4 of 18 (22.2%)	Not reported
After Follow-up Visit	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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 6 inclusion and 11 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 12 Jan 2015. 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 12 Jan 2015). 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 - Maximum Plasma Concentration (time frame: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period). 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 NCT02284880.

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 12 Jan 2015.