Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093
Intervention description: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine acetate; BIA 2-093

Summary:

      The purpose of this study is to determine the effects of age on the pharmacokinetic profile
      of BIA 2-093 and its active metabolites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged between 18 and 40 years, inclusive OR male or female
             subjects aged 65 years or more.

          -  If young, subjects who were within 15% of ideal body weight OR, if elderly, subjects
             who were within 20% of ideal body weight according to the Metropolitan Life Insurance
             Table.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, neurological examination, and 12-lead ECG.

          -  Subjects who had clinical laboratory tests acceptable to the Investigator.

          -  Subjects who were negative for HBsAg, HCVAb 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 smoked 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 menopause
             or, if of childbearing potential, she used one of the following methods of
             contraception: double barrier or intrauterine.

          -  (If female and with less than 40 years old) She had a negative pregnancy test at
             screening.

        Exclusion Criteria:

          -  Subjects who did not conform to the above inclusion criteria.

          -  Subjects who had a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, 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 atopy.

          -  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 had a significant infection or known inflammatory process on screening
             and/or admission.

          -  Subjects who had acute gastrointestinal symptoms at the time of screening and/or
             admission (e.g., nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who had used drugs within 2 weeks of first dosing.

          -  Subjects who had used any investigational drug and/or participated in any clinical
             trial within 3 months of their first admission to this study.

          -  Subjects who had previously received BIA 2-093.

          -  Subjects who had donated and/or received any blood or blood products within the
             previous 2 months prior to screening.

          -  Subjects who were vegetarians, vegans and/or had 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 use an authorised
             effective contraceptive method.