Overview
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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.