The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Steady-state Plasma Concentration
研究概览
简要总结
The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.
详细描述
Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female subjects aged between 18 and 45 years, inclusive.
- •Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- •Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
- •Subjects who had clinical laboratory tests clinically acceptable.
- •Subjects who were negative for HBs Ag, anti-HCV Ab and anti-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 give written informed consent.
- •In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device.
- •In case of female volunteers, subjects who 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 respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- •Subjects who had a clinically relevant surgical history.
- •Subjects who had a clinically relevant family history.
- •Subjects who had a history of relevant atopy.
- •Subjects who had a history of relevant drug hypersensitivity.
- •Subjects who had a history of alcoholism or drug abuse.
- •Subjects who consumed more than 14 units of alcohol a week.
- •Subjects who had any of the following findings on the ECG: QTc interval >440 msec; first-, second- or third-degree atrioventricular block; atrial fibrillation; heart rate below 50 bpm; any other relevant abnormality.
- •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 prescription drugs within 4 weeks of first dosing.
- •Subjects who had used over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months of their first admission.
- •Subjects who had previously received BIA 2-
- •Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
- •Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
- •Subjects who could not 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 give written informed consent.
- •In case of female volunteers, subjects who were pregnant or breast-feeding.
- •In case of female volunteers, subjects who were of childbearing potential and did not use an authorized effective contraceptive method.
研究组 & 干预措施
BIA 2-093
BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate
Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
干预措施: BIA 2-093 (Drug)
BIA 2-093
BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate
Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
干预措施: Digoxin (Drug)
Placebo
Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo
Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
干预措施: Placebo (Drug)
Placebo
Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo
Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
干预措施: Digoxin (Drug)
结局指标
主要结局
Cmax - Maximum Steady-state Plasma Concentration
时间窗: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose
Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin
次要结局
- Tmax - Time of Occurrence of Cmax at Steady-state(Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose)
- AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h(Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose)