A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
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
- 20 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eszopiclone 3 mg tablet
干预措施: Eszopiclone 3 mg (Drug)
Eszopiclone 1 mg tablet
干预措施: Eszopiclone 1 mg (Drug)
结局指标
主要结局
Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
时间窗: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
时间窗: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng\*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
时间窗: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
时间窗: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng\*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
次要结局
未报告次要终点