Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers

Overview

Single centre, randomised, open-label, two-way crossover study to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2007

Interventions

  • Drug: BIA 2-093
  • Drug: Gliclazide
    • tablets containing gliclazide 80 mg (Diamicron® 80 mg)

Arms, Groups and Cohorts

  • Experimental: Group A
    • Period 1 – BIA 2-093 + Gliclazide Period 2 – Gliclazide
  • Experimental: Group B
    • Period 1 – Gliclazide Period 2 – BIA 2-093 + Gliclazide

Clinical Trial Outcome Measures

Primary Measures

  • Cmax
    • Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose
    • Maximum plasma concentration (Cmax) of Gliclazide following a single oral dose of 80 mg administered alone
  • Tmax
    • Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose
    • Time to maximum observed concentration (Tmax) of Gliclazide following a single oral dose of 80 mg administered alone
  • AUC0-12
    • Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose
    • Area under the plasma concentration-time curve over 12 hours (AUC0-12) of Gliclazide following a single oral dose of 80 mg administered alone
  • AUC0-∞
    • Time Frame: before the gliclazide dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h post-gliclazide dose
    • Area under the concentration-time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-∞) of Gliclazide following a single oral dose of 80 mg administered alone

Participating in This Clinical Trial

Inclusion Criteria

Subjects were eligible for the study if they fulfilled all of the following 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:

Subjects were not eligible for the study if they fulfilled any of the following 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bial – Portela C S.A.
  • Provider of Information About this Clinical Study
    • Sponsor

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