A Dose Randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of Zebinix (Eslicarbazepine Acetate) After Oral Administration in Healthy Korean and Caucasian Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time of maximum observed drug concentration (Tmax)
研究概览
简要总结
A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19-45 years at screening
- •Subjects who weigh more than 50kg with a body mass index(BMI) of 18.0~28.0 kg/m2 at screening
- •Subjects who are fully understood after being given the detailed explanation of this clinical trial and willing to give written informed consent for participation prior to the screening test
- •Subjects who are qualified to participate in this clinical trial through the physical examination, clinical laboratory test and interview by the investigators
排除标准
- •Clinically significant presence or treatment history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, psychiatric
- •Clinically significant surgical history
- •Clinically significant family history
- •Clinically significant atopic syndrome
- •History of hypersensitivity or clinically significant hypersensitivity to drug including carbamazepine and related compounds
- •History of alcoholism or drug abuse or show a positive response to an abuse drug in the urine drug screening test
- •Consistently consume alcohol or cannot stop drinking during the clinical trial
- •Significant infection or inflammatory finding at screening visit
- •History of gastrointestinal disorders or surgery which may have an effect on the safety and pharmacokinetic evaluation of the investigational products (except for simple appendectomy and herniotomy)
- •Have used prescription drugs or herbal medication within 2 weeks of initial administration or who have used over the counter(OTC), health functional food or vitamins within 1 week of initial administration (but, if the other conditions are suitable according to the judgment of the investigator, they can participate in the clinical trial), or subjects who have expected to take it
- •Have participated in any clinical trial (or bioequivalence study) and administered any investigational product within 6 months
- •Positive for HbsAg, anti-HCV and HIV antigen-antibody reaction tests at screening
- •Have donated any whole blood or apheresis or received blood transfusion within 3 months of initial administration of this clinical trial
- •Have dietary restrictions or cannot take the food provided by the institution
- •Cannot communicate reliably with the investigator
- •Subjects who are determined by the investigator to be ineligible for participation in this clinical trial due to clinical laboratory test results or other reasons
研究组 & 干预措施
Zebinix 400mg
干预措施: Zebinix 400mg (Drug)
Placebo for Zebinix 400mg
干预措施: Placebo for Zebinix 400mg (Drug)
Zebinix 800mg
干预措施: Zebinix 800mg (Drug)
Placebo for Zebinix 800mg
干预措施: Placebo for Zebinix 800mg (Drug)
Zebinix 1600mg
干预措施: Zebinix 1600mg (Drug)
Placebo for Zebinix 1600mg
干预措施: Placebo for Zebinix 1600mg (Drug)
结局指标
主要结局
Time of maximum observed drug concentration (Tmax)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Maximum observed plasma drug concentration (Cmax)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Area under the plasma concentration time-curve (AUC)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Apparent terminal elimination half-life (t1/2)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Peak trough fluctuation (PTF)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Accumulation ratio (R)
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
Metabolic ratio
时间窗: 'Day 1' 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose, 'Day 6~Day 11' 0 hour(pre-dose), 'Day 11' 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 hour post-dose
次要结局
- Adverse event(Day -1 ~ Day 15)