A Randomized, Open-Label, Single-Dose, 2-Period Crossover Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of Lacosamide (LCM)
研究概览
简要总结
The purpose of this study is to demonstrate bioequivalence between the LCM tablet and syrup after single oral dosing in healthy Chinese male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a Chinese male between 18 and 40 years of age
- •Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
- •Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used
排除标准
- •Clinically significant
- •out of range values for hematology and clinical chemistry variables
- •abnormality in physical examination or vital signs
- •ECG finding Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
研究组 & 干预措施
Treatment A - B
Single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions
干预措施: Lacosamide (LCM) tablet (Drug)
Treatment A - B
Single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions
干预措施: Lacosamide (LCM) syrup (Drug)
Treatment B - A
Single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg) under fasting conditions
干预措施: Lacosamide (LCM) tablet (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of Lacosamide (LCM)
时间窗: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.
Area under the LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])
时间窗: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule.
Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)
时间窗: Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing
Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.
次要结局
- Apparent volume of distribution (Vz/F) of LCM(Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing)
- Terminal plasma elimination half-life (t1/2) of LCM(Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing)
- Time of observed Cmax (tmax) of LCM(Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing)
- Apparent plasma clearance (CL/F) of LCM(Blood samples are collected at predose and 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours after dosing)