Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Oxcarbazepine
Intervention description: Tablets containing BIA 2-093 in doses of 300 and 600 mg; Tablets containing 300 mg and 600 mg of Trileptal®
Intervention MeSH terms: Eslicarbazepine acetate; Oxcarbazepine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Eslicarbazepine acetate; Epilepsy; Oxcarbazepine

Summary:

      To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single
      900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a
      single 900 mg dose of BIA 2-093 and Oxcarbazepine.
    

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, neurological examination, and 12-lead ECG.

          -  Subjects who had clinical laboratory tests acceptable.

          -  Subjects who were negative for HBs Ag, 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.

          -  In case of female volunteers, subjects who were not of childbearing potential by
             reason of surgery or, if of childbearing potential, used one of the following methods
             of contraception: double-barrier, intrauterine device or abstinence.

          -  In case of female volunteers, subjects who had a negative pregnancy test at screening
             and admission

        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 used prescription drugs within 4 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 2 months of their first admission.

          -  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.

          -  In case of female volunteers, subjects who were pregnant or breast-feeding.

          -  In case of female volunteers, subjects who were of childbearing potential and did not
             use an approved effective contraceptive method or used oral contraceptives.