Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; BIA 2-093; BIA 2-093
Intervention description: oral suspension 50 mg/mL; 200 mg tablet; 800 mg tablet
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: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9
      males and 9 females). The study consisted of three consecutive single-dose treatment periods
      separated by a washout period of 7 days or more. On each treatment period, the volunteers
      received a single dose of BIA 2-093 800 mg, orally.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged between 18 and 45 years, inclusive.

          -  Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, vital signs and 12-lead ECG at screening.

          -  Subjects who had clinical laboratory tests clinically acceptable at screening.

          -  Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at
             screening.

          -  Subjects who were negative for alcohol and drugs of abuse at screening.

          -  Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per
             day.

          -  Subjects who were able and willing to give written informed consent.

          -  (If female) She was not of childbearing potential by reason of surgery or, if of
             childbearing potential, she used one of the following methods of contraception:
             doublebarrier, intra-uterine device or abstinence.

          -  (If female) She had a negative pregnancy test at screening and admission to each study
             period.

        Exclusion Criteria:

          -  Subjects who do not conform to the above inclusion criteria, or

          -  Subjects who have 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 have a clinically relevant surgical history.

          -  Subjects who have a clinically relevant family history.

          -  Subjects who have a history of relevant atopy.

          -  Subjects who have a history of any drug hypersensitivity.

          -  Subjects who have a history of alcoholism or drug abuse.

          -  Subjects who consume more than 14 units of alcohol a week.

          -  Subjects who have a significant infection or known inflammatory process on screening
             and/or first admission.

          -  Subjects who have acute gastrointestinal symptoms at the time of screening and/or
             first admission (e.g., nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who have used medicines within 2 weeks of admission to first period.

          -  Subjects who have participated in any clinical trial within 3 months prior to
             screening.

          -  Subjects who have previously received BIA 2-093.

          -  Subjects who have donated and/or received any blood or blood products within the
             previous 3 months prior to screening.

          -  Subjects who are vegetarians, vegans and/or have medical dietary restrictions.

          -  Subjects who cannot communicate reliably with the investigation team.

          -  Subjects who are unlikely to co-operate with the requirements of the study.

          -  Subjects who are unwilling or unable to give written informed consent.

          -  (If female) She is pregnant or breast-feeding.

          -  (If female) She is of childbearing potential and she does not use an approved
             effective contraceptive method or she uses oral contraceptives.