Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A
Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide
干预措施: BIA 2-093 (Drug)
Group A
Period 1 - BIA 2-093 + Gliclazide Period 2 - Gliclazide
干预措施: Gliclazide (Drug)
Group B
Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide
干预措施: BIA 2-093 (Drug)
Group B
Period 1 - Gliclazide Period 2 - BIA 2-093 + Gliclazide
干预措施: Gliclazide (Drug)
结局指标
主要结局
Tmax
时间窗: 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
时间窗: 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
时间窗: 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-∞
时间窗: 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
次要结局
未报告次要终点