Epilepsy
Conditions
Brief 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.
Interventions
DRUGBIA 2-093
DRUGGliclazide
tablets containing gliclazide 80 mg (Diamicron® 80 mg)
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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 | 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 | 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-∞ | 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 |
Countries
Portugal
Outcome results
None listed