Overview

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

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Eslicarbazepine acetate
Gliclazide
Criteria
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.