Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Phenytoin
Intervention MeSH terms: Eslicarbazepine acetate; Phenytoin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single centre, open-label, multiple doses, two parallel study groups each receiving two
      formulations in a one-sequence design
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability of volunteer for the entire study period and willingness to adhere to
             protocol requirements as evidenced by the informed consent form (ICF) duly read,
             signed and dated by the volunteer

          -  Non-black male aged of at least 18 years but not older than 45 years with a body mass
             index (BMI) greater than or equal to 19 and below 30 kg/m2

          -  Clinical laboratory values within the laboratory's stated normal range; if not within
             this range, they must be without any clinical significance (laboratory tests are
             presented in section 6.1.1.3)

          -  Healthy according to the medical history, laboratory results and physical examination

          -  Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes
             or less per day, and an ex-smoker is defined as someone who completely stopped smoking
             for at least 12 months before day 1 of this study

        Exclusion Criteria:

          -  Significant history of hypersensitivity to phenytoin, eslicarbazepine, oxcarbazepine,
             carbamazepine or any related products (including excipients of the formulations) as
             well as severe hypersensitivity reactions (like angioedema) to any drugs

          -  Presence of significant gastrointestinal, liver or kidney disease, or any other
             conditions known to interfere with the absorption, distribution, metabolism or
             excretion of drugs or known to potentiate or predispose to undesired effects

          -  History of significant gastrointestinal, liver or kidney disease, or surgery that may
             affect drug bioavailability, including but not limited to cholecystectomy

          -  Presence of significant cardiovascular, pulmonary, hematologic, neurologic,
             psychiatric, endocrine, immunologic or dermatologic disease

          -  Presence of significant heart disease or disorder according to ECG

          -  Presence or history of significant central nervous system disorder like convulsion or
             depression

          -  Hemoglobin count below 135 g/L (at screening)

          -  Use of valproic acid in the previous 7 days prior to Day 1 of the study.

          -  Maintenance therapy with any drug, or significant history of drug dependency or
             alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or
             chronic)

          -  Any clinically significant illness in the previous 28 days before day 1 of this study

          -  Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
             (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,
             fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP
             enzymes (such as barbiturates, carbamazepine, glucocorticoids,phenytoin and rifampin),
             in the previous 28 days before Day 1 of this study.