Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Metformin; Eslicarbazepine acetate
Intervention description: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days
Intervention MeSH terms: Metformin; Eslicarbazepine acetate
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: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: eslicarbazepine acetate; zebinix; metformin

Summary:

      The primary objective was to investigate whether multiple-dose administration of
      eslicarbazepine acetate affects the pharmacokinetics of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged between 18 and 45 years, inclusive.

          -  Body mass index (BMI) between 19 and 30 kg/m2, inclusive.

          -  Healthy as determined by pre-study medical history, physical examination, vital signs,
             complete neurological examination and 12-lead ECG.

          -  Negative tests for HBsAg, anti-HCVAb and 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 who smoke ≤ 10 cigarettes or equivalent per day.

          -  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 one of the following methods of contraception: double barrier or
             intrauterine device.

          -  (If female) 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.

          -  Clinically relevant surgical history.

          -  History of relevant atopy or drug hypersensitivity.

          -  History of alcoholism or drug abuse.

          -  Consumed more than 14 units of alcohol a week.

          -  Significant infection or known inflammatory process at 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.

          -  Used medicines within 2 weeks of admission to first period that may affect the safety
             or other study assessments, in the investigator's opinion.

          -  Used any investigational drug or participated in any clinical trial within 6 months
             prior to screening.

          -  Participated in more than 2 clinical trials within the 12 months prior to screening.

          -  Donated or received any blood or blood products within the 3 months prior to
             screening.

          -  Vegetarians, vegans or with medical dietary restrictions.

          -  Could not communicate reliably with the investigator.

          -  Unlikely to co-operate with the requirements of the study.

          -  Unwilling or unable to give written informed consent.

          -  (If female) Pregnant or breast-feeding.

          -  (If female) Of childbearing potential and she did not use an approved effective
             contraceptive method (double-barrier or intra-uterine device) or she used oral
             contraceptives.