NCT01986608已完成1 期
A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion in Healthy Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide
研究概览
简要总结
This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and female volunteers with the age between 20 and 55 years old
排除标准
- •Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months
- •Subject has a history (within 6 months) before screening visit of chronic alcohol and/or drug abuse and/or has smoked and/or has a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, or neurological disorders
- •Subject has a history of suicide attempt or current active suicidal ideation
- •Subject has experienced a myocardial infarction and/or made a blood donation or any other blood loss more than 400 ml in the last 3 months
- •Subject is pregnant or nursing
- •Subject is not healthy (eg, taking any drug treatments, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters and/or was positive for HIV, HBsAg, HCV)
- •Subject has an excessive use of alcohol or/and cigarettes and/or caffeine and/or abnormal diet and/or has taken grapefruit or grapefruit drink within 7 days before intake of Investigational Medicinal Product (IMP)
- •Subject has a clinically significant abnormality in the 12-lead Electrocardiogram (ECG)
- •Subject is having clinically relevant drug hypersensitivity to any components of the investigational medicinal product
研究组 & 干预措施
Lacosamide 30-minute iv
Experimental
A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).
干预措施: Lacosamide infusion (Drug)
Lacosamide 60-minute iv
Experimental
60-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).
干预措施: Lacosamide infusion (Drug)
Lacosamide oral tablet
Experimental
Oral administration of Lacosamide (LCM) 200 mg (2 x 100 mg film-coated tablet) with 200 mL of water.
干预措施: Lacosamide oral (Drug)
结局指标
主要结局
Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide
时间窗: Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion)
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide
时间窗: Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion)
次要结局
- Mean residence time (MRT) after oral and intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Total body clearance (CL) after intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Apparent total body clearance (CL/F) after oral administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Apparent volume of distribution (Vz/F) after oral administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
- Volume of distribution (Vz) after intravenous administration of Lacosamide(Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion))
研究者
研究点 (1)
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