Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
- Registration Number
- NCT02777671
- Lead Sponsor
- Bial - Portela C S.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A Gliclazide Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide Group A BIA 2-093 Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide Group B BIA 2-093 Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide Group B Gliclazide Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Human Pharmacology Unit
🇵🇹S. Mamede do Coronado, Portugal