Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Carbamazepine
Intervention MeSH terms: Carbamazepine; Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the
      effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ
      pharmacokinetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18 to 45 years inclusive;

          -  Body mass index (BMI) between 18 and 30 kg/m2 inclusive;

          -  Healthy as determined by pre-study medical history, physical examination, vital signs,
             and 12-lead electrocardiogram (ECG); negative tests for Hepatitis B surface Antigen
             (HBsAg), anti-HCVAb and Human Immunodeficiency Virus (HIV)-1 and HIV-2 Ab at
             screening;

          -  Clinical laboratory test results clinically acceptable at screening and admission to
             each treatment period;

          -  Negative screen for alcohol and drugs of abuse at screening and admission to each
             treatment period;

          -  Non-smokers or ex-smokers;

          -  Able and willing to give written informed consent;

          -  If female, not of childbearing potential by reason of surgery or, if of childbearing
             potential, she used a double-barrier method of contraception: 1 male barrier method
             [male condom] plus 1 female barrier method (diaphragm, spermicide, or intrauterine
             device);

          -  If female, had a negative urine pregnancy test at screening and admission to each
             treatment period.

        Exclusion Criteria:

          -  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; have a clinically relevant surgical history;

          -  History of relevant atopy or any drug hypersensitivity (including known
             hypersensitivity to ESL or other carboxamide derivatives [e.g., carbamazepine,
             oxcarbazepine] or any of its excipients; known hypersensitivity to drugs structurally
             related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);

          -  Second or third-degree atrioventricular blockade not corrected with a pace-maker or
             any other clinically significant abnormality in the 12-lead ECG as determined by the
             investigator;

          -  History of alcoholism or drug abuse;

          -  Consumed more than 14 units1 of alcohol a week;

          -  Significant infection or known inflammatory process on screening or admission to each
             treatment period;

          -  Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the
             time of screening or admission to each treatment period;

          -  Use of medicines within two weeks of admission to first period that may affect the
             safety or other study assessments, in the investigator's opinion;

          -  Had donated or received any blood or blood products within the 3 months prior to
             screening;

          -  Vegetarians, vegans or have other medical dietary restrictions;

          -  Could not communicate reliably with the investigator; was unlikely to co-operate with
             the requirements of the study;

          -  Unwilling or unable to give written informed consent;

          -  If female, was pregnant or breast-feeding;

          -  If female, was of childbearing potential and did not use an accepted effective
             contraceptive method or used hormonal contraceptives;

          -  Had received an investigational drug within 3 months of screening or was currently
             participating in another study.