Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence
      study in 18 healthy male and female subjects.
    

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.