An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine the Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) in Patients With Refractory Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 22
- 主要终点
- AUC 0-24h
研究概览
简要总结
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)
详细描述
To determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (Diastat®) under conditions of use in adolescent and adult persons with epilepsy (PWE) meeting the definition of refractory epilepsy.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of refractory epilepsy
- •Body weight 26 to 111 kilogram (kg) inclusive
- •Other inclusion criteria apply
排除标准
- •Male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product
- •Female subject who is pregnant, breastfeeding, or planning to become pregnant
- •Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
- •Other exclusion criteria apply
研究组 & 干预措施
diazepam nasal spray (DZNS)
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
干预措施: diazepam nasal spray (Drug)
diazepam rectal gel (DRG)
A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.
干预措施: diazepam rectal gel (Drug)
结局指标
主要结局
AUC 0-24h
时间窗: 24 hours
Relative bioavailability based on area under time plasma concentration curve.
Cmax
时间窗: 24 hours
Relative bioavailability based on maximum observed plasma concentration.
次要结局
- Focused Nasal Exam (Part B)(pre-dose (day 1) up to 24 hours post-dose)
- Focused Nasal Exam (Part A)(pre-dose (day 1) up to 24 hours post-dose)
- Smell Identification Test (SIT)(day 1 up to day 31)
- Taste Change Questionnaire(Up to 24 hours)