The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Adverse Events reported
研究概览
简要总结
The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA 2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the tolerability and safety of ESL administered concomitantly with phenytoin in patients.
详细描述
This study was planned as a single-dose, open label phase (Phase A) followed by a multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover phase (Phase B) study in patients taking phenytoin. Phase B consisted of two 14-day treatment periods separated by a washout period of 10 to 15 days. Subjects continued their usual phenytoin scheme and received a single dose of ESL 1200 mg (Phase A) and either ESL (600 mg from Day 1 to 7 and 1200 mg from Day 8 to 14) or matching placebo once-daily for 14 days in each period.
The study was prematurely terminated due to impossibility of recruiting the planned number of patients. Only 4 patients were admitted and this was considered a too small sample size to allow a reliable assessment of the potential interaction between ESL and phenytoin. Therefore, no pharmacokinetic evaluation was performed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged between 18 and 65 years, inclusive.
- •Subjects who were on an established regimen of phenytoin monotherapy, which had been stable for at least 3 months.
- •Subjects who had clinical laboratory tests acceptable to the Investigator.
- •Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab) and human immunodeficiency viruses (HIV-1 and HIV-2) Ab tests at screening.
- •Subjects who were negative for alcohol and drugs of abuse at screening.
- •Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
- •Subjects who were able and willing to gave written informed consent.
- •(If female) She was 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) She had a negative pregnancy test at screening.
排除标准
- •Subjects who did not conform to the above inclusion criteria.
- •Subjects who had a clinically relevant history or presence of any disease that may interfere with the pharmacokinetics or pharmacodynamics of the Investigational Products, or may affect its safety.
- •Subjects who had a history of relevant drug hypersensitivity.
- •Subjects who had a history of alcoholism or drug abuse in the last 2 years.
- •Subjects who consumed more than 21 units of alcohol a week.
- •Subjects who had one of the following findings on the electrocardiogram (ECG): sinus bradycardia, sinoatrial block, atrioventricular block of any degree.
- •Subjects who had a significant infection or known inflammatory process on screening and/or admission.
- •Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- •Subjects who had used any drugs (other than phenytoin) that may affect the pharmacokinetic profile of the investigational products within 2 weeks of first dosing.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
- •Subjects who had previously received ESL.
- •Subjects who had donated and/or received any blood or blood products within the previous 3 months prior to screening.
- •Subjects who were vegetarians, vegans and/or have medical dietary restrictions.
- •Subjects who cannot communicate reliably with the investigator.
- •Subjects who were unlikely to co-operate with the requirements of the study.
- •Subjects who were unwilling or unable to gave written informed consent.
- •(If female) She was pregnant or breast-feeding.
- •(If female) She was of childbearing potential and she did not use an approved effective contraceptive method.
研究组 & 干预措施
Eslicarbazepine acetate
ESL 600 mg tablets
干预措施: Eslicarbazepine acetate (Drug)
phenytoin
Hidantina® 100 mg tablets
干预措施: phenytoin (Drug)
Placebo
Placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Adverse Events reported
时间窗: 3 weeks
Number of the adverse events reported
次要结局
未报告次要终点