A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Topamax
Intervention MeSH terms: Topiramate; Eslicarbazepine acetate
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, one-sequence design study in two parallel groups
      of healthy volunteers
    

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

          -  Male aged of at least 18 years but not older than 45 years with a body mass índex
             (BMI) greater than or equal to 19 and below 30 kg/m

          -  Clinical laboratory values within the laboratory's stated normal range; i f 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

          -  Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0
             cigarettes or less per day, and an ex-smoker i s defined as someone who completely
             stopped smoking for at least 1 2 months before day 1 of this study

        Exclusion Criteria:

          -  Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine,
             carbamazepine or any related products (including excipients of the formulations) as
             wel l as severe hypersensitivity reactions (like angioedema) to any drugs

          -  Presence of significant gastrointestinal, l iver 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 o r kidney disease, o r surgery that
             may affect drug bioavailability, including but not limited to cholecystectomy

          -  Presence of significant cardiovascular, pulmonary, hematologic, neurologic,
             psychiatric, endocrine, immunologic or dermatologic d isease

          -  Presence o f significant heart disease o r disorder according to ECG

          -  Presence or history of significant central nervous system disorder l ike convulsion or
             depression

          -  Presence o r history o f significant ocular disease

          -  Presence or history of severe hepatic impairment

          -  Presence or history of renal insufficiency (serum creatinine level greater than 135
             μmol/L)

          -  History or presence of acidosis

          -  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

          -  Participation in another clinical trial or donation of 50 mL or more of blood in the
             previous 28 days before day 1 of this study

          -  Donation of 500 mL or more of blood (Canadian B lood Services, Hema-Quebec, clinical
             studies, etc.) in the previous 56 days before day 1 of this study

          -  Positive urine screening of drugs of abuse (drugs listing is presented in section
             6.1.1.4).

          -  Positive results to HIV, HBsAg or anti-HCV tests