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Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIA 2-093
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female subjects aged between 18 and 55 years, inclusive.
  • Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.
  • Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
  • Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.
  • Subjects who had a negative screen for alcohol and drugs of abuse at screening.
  • Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.
  • Subjects who were able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).
  • (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, or
  • Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Subjects who had a clinically relevant surgical history.
  • Subjects who had a clinically relevant family history.
  • Subjects who had a history of relevant drug hypersensitivity.
  • Subjects who had a history of alcoholism or drug abuse.
  • Subjects who consumed more than 14 units of alcohol a week.
  • Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
  • Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
  • Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093).
  • Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
  • Subjects who were vegetarians, vegans or have medical dietary restrictions.
  • Subjects who could not communicate reliably with the investigator.
  • Subjects who were unlikely to co-operate with the requirements of the study.
  • Subjects who were unwilling or unable to give written informed consent.
  • (If female) She was pregnant or breast-feeding.
  • (If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    BIA 2-093 800 mg fasting

    BIA 2-093 800 mg fed

    BIA 2-093 400 mg

    Arm Description

    Tablets 800 mg. Administration:Oral.

    Tablets 800 mg. Administration:Oral.

    Tablets 2 x 400 mg. Administration:Oral.

    Outcomes

    Primary Outcome Measures

    Cmax (BIA 2-005)
    Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)

    Secondary Outcome Measures

    AUC0-t (BIA 2-005)
    AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)
    Tmax (BIA 2-005)
    tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)
    AUC0-∞ (BIA 2-005)
    AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)

    Full Information

    First Posted
    November 7, 2014
    Last Updated
    December 19, 2014
    Sponsor
    Bial - Portela C S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02288312
    Brief Title
    Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
    Official Title
    Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bial - Portela C S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.
    Detailed Description
    Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BIA 2-093 800 mg fasting
    Arm Type
    Experimental
    Arm Description
    Tablets 800 mg. Administration:Oral.
    Arm Title
    BIA 2-093 800 mg fed
    Arm Type
    Experimental
    Arm Description
    Tablets 800 mg. Administration:Oral.
    Arm Title
    BIA 2-093 400 mg
    Arm Type
    Experimental
    Arm Description
    Tablets 2 x 400 mg. Administration:Oral.
    Intervention Type
    Drug
    Intervention Name(s)
    BIA 2-093
    Other Intervention Name(s)
    ESL, Eslicarbazepine acetate
    Primary Outcome Measure Information:
    Title
    Cmax (BIA 2-005)
    Description
    Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)
    Time Frame
    pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.
    Secondary Outcome Measure Information:
    Title
    AUC0-t (BIA 2-005)
    Description
    AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)
    Time Frame
    pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.
    Title
    Tmax (BIA 2-005)
    Description
    tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)
    Time Frame
    pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.
    Title
    AUC0-∞ (BIA 2-005)
    Description
    AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)
    Time Frame
    pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects aged between 18 and 55 years, inclusive. Subjects of body mass index (BMI, kg/m2) within the normal range [4], i.e., between 18.50 and 24.99, inclusive. Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG. Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period. Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening. Subjects who had a negative screen for alcohol and drugs of abuse at screening. Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission. Subjects who were able and willing to give written informed consent. (If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner). (If female) She had a negative urine pregnancy test at screening and admission to each treatment period. Exclusion Criteria: Subjects who did not conform to the above inclusion criteria, or Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. Subjects who had a clinically relevant surgical history. Subjects who had a clinically relevant family history. Subjects who had a history of relevant drug hypersensitivity. Subjects who had a history of alcoholism or drug abuse. Subjects who consumed more than 14 units of alcohol a week. Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments. Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission. Subjects who had previously received eslicarbazepine acetate (ESL, BIA 2-093). Subjects who donated or received any blood or blood products within the previous 2 months prior to screening. Subjects who were vegetarians, vegans or have medical dietary restrictions. Subjects who could not communicate reliably with the investigator. Subjects who were unlikely to co-operate with the requirements of the study. Subjects who were unwilling or unable to give written informed consent. (If female) She was pregnant or breast-feeding. (If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.

    12. IPD Sharing Statement

    Learn more about this trial

    Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate

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