Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Oxcarbazepine
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: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epilepsy; Oxcarbazepine; Eslicarbazepine Acetate; BIA 2-093

Summary:

      To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of
      BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to
      assess the tolerability of such regimens in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were eligible for entry into the study if they fulfilled the following
             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 clinically acceptable.

          -  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 first
             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.

          -  If case of female subjects, subjects who were not of childbearing potential by reason
             of surgery or, if of childbearing potential, who used one of the following methods of
             contraception: double-barrier, intrauterine device or abstinence.

          -  If case of female subjects, subjects who had a negative pregnancy test at screening
             and first 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, 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 atopy.

          -  Subjects who had a history of hypersensitivity to carbamazepine or oxcarbazepine or
             any other 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 first admission.

          -  Subjects who had acute gastrointestinal symptoms at the time of screening and/or first
             admission (e.g., nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who had used prescription or over-the-counter medication within two weeks of
             first admission.

          -  Subjects who had used any investigational drug and/or participated in any clinical
             trial within four 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 4 months prior to screening.

          -  Subjects who were vegetarians, vegans and/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.

          -  In case of female subjects, subjects who were pregnant or breast-feeding.

          -  In case of female subjects, subjects who were of childbearing potential and did not
             use an approved effective contraceptive method or used oral contraceptives.