The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BIA 2-093; Eslicarbazepine acetate

Summary:

      The purpose of this study is to investigate the effect of food on the pharmacokinetics of a
      single 800 mg oral dose of BIA 2-093 in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects were eligible for entry into the study if they fulfilled the following inclusion
        criteria:

          -  Male 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, neurological examination, EEG, and 12-lead ECG.

          -  Subjects who had clinical laboratory tests clinically acceptable to the investigator.

          -  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 and admission.

          -  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.

        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 21 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 an acute infection such as influenza at the time of screening and/or
             admission.

          -  Subjects who had used prescription drugs within four weeks of first dosing.

          -  Subjects who had used over-the-counter medication excluding oral routine vitamins but
             including mega dose vitamin therapy within one week of first dosing.

          -  Subjects who had used any investigational drug and/or participated in any clinical
             trial within two 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 two 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.