An Open-Label Study to Determine the Pharmacokinetics of a Single Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode for Which Acute Treatment With a Benzodiazepine is Clinically Indicated
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent for study participation.
- •General good health with no clinically significant unstable abnormalities.
- •Diagnosis of epilepsy.
排除标准
- •Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
- •Use of any investigational drug within 30 days.
- •Blood or plasma donation within 30 days.
- •Not willing or unable to tolerate blood draws.
研究组 & 干预措施
Diazepam Nasal Spray
干预措施: Diazepam (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)
时间窗: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax. The mean Tmax value was adjusted to a 20 mg dose.
Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration
时间窗: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last). The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours.
Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),
时间窗: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.
次要结局
- Number of Patients With Treatment Emergent Adverse Events (TEAEs)(Pre-dose to 48 hours post-dose)