Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; Contraceptives, Oral, Combined
Intervention MeSH terms: Eslicarbazepine acetate; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single centre, two-way crossover, randomised, open-label study in 20 healthy female
      volunteers.The volunteers received an oral single-dose of a combined contraceptive containing
      with an oral once daily dose of 1200 mg of BIA 2-093
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal female;

          -  Able and willing to give written informed consent;

          -  Aged 18 to 40 years, inclusive;

          -  Not pregnant or breast-feeding;

          -  Body mass index (BMI) between 19 and 30 kg/m2, inclusive;

          -  Healthy as determined by medical history, physical examination, complete neurological
             examination, vital signs, and 12-lead ECG;

          -  Clinical laboratory tests with clinically acceptable results at screening and
             admission to the first period;

          -  Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;

          -  Negative test for drugs of abuse at screening;

          -  Non-smoker or smokes less than 10 cigarettes or equivalent per day;

          -  Agreed to either practice abstinence or use a double-barrier or intra-uterine device
             from screening until the follow-up visit;

          -  Negative pregnancy test at screening and admission to the first period.

        Exclusion Criteria:

          -  Had any contra-indication to the use of oral contraceptives;

          -  Had experienced notable adverse events while on any oral contraceptive;

          -  Had a history of alcoholism or drug abuse;

          -  Had a relevant history or presence of respiratory, gastrointestinal, renal,
             hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric,
             musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective
             tissue diseases or disorders;

          -  Had acute gastrointestinal symptoms at the time of screening or admission to the first
             period;

          -  Had a significant infection or inflammatory process at the time of screening or
             admission to the first period;

          -  Had a relevant surgical history;

          -  Had a relevant family history;

          -  Had a history of relevant drug hypersensitivity (e.g., carbamazepine or
             oxcarbazepine);

          -  Had used relevant prescription or over-the-counter medication within 2 weeks
             ofadmission to the first period;

          -  Consumed more than 14 units of alcohol a week;

          -  Had participated in any clinical trial within 3 months prior to screening;

          -  Had previously received BIA 2-093;

          -  Had donated or received any blood or blood products within 2 months prior to
             screening;

          -  Was unlikely to co-operate with the requirements of the study.