Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Plasma Drug Concentration
研究概览
简要总结
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.
详细描述
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.
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 entry into the study if they fulfilled the following inclusion criteria:
- •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 HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- •Subjects who were negative for alcohol and drugs of abuse at screening and first admission.
- •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.
- •If case of female subjects, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, who used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
- •If case of female subjects, subjects who had a negative pregnancy test at screening and first admission.
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 hypersensitivity to carbamazepine or oxcarbazepine or any other 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 a significant infection or known inflammatory process on screening and/or first admission.
- •Subjects who had acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- •Subjects who had used prescription or over-the-counter medication within two weeks of first admission.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within four 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 4 months prior to screening.
- •Subjects who were vegetarians, vegans and/or have 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 subjects, subjects who were pregnant or breast-feeding.
- •In case of female subjects, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.
研究组 & 干预措施
Group A
BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period
BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid
干预措施: BIA 2-093 (Drug)
Group A
BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period
BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid
干预措施: Oxcarbazepine (Drug)
Group B
BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od
干预措施: BIA 2-093 (Drug)
Group B
BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period
BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od
干预措施: Oxcarbazepine (Drug)
Group C
oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period
OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
干预措施: BIA 2-093 (Drug)
Group C
oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period
OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Drug Concentration
时间窗: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
次要结局
- AUC - Area Under the Plasma Concentration Versus Time Curve(pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose)
- Number of of Subjects Reporting at Least One Adverse Event(8 weeks)