A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum measured plasma concentration (Cmax)
研究概览
简要总结
This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening body weight 88 to 111 kg, inclusive;
- •General good health with no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, visual evaluation of the septum and turbinates to document baseline anatomy, electrocardiogram, clinical laboratory test results;
- •Negative drug and alcohol testing;
- •Negative pregnancy test for female subjects of childbearing potential.
排除标准
- •Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who 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;
- •In the judgment of the Investigator, any clinically significant abnormality (such as septal perforations) or illness that would interfere with participation in this study as determined by medical history, physical examination (including visual exam of septum and turbinates), ECG, clinical laboratory results, or other screening safety tests;
- •Any other condition and/or situation that causes the investigator to deem a subject unsuitable for the study.
研究组 & 干预措施
diazepam nasal spray (AB)
Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA).
干预措施: diazepam nasal spray (Drug)
diazepam nasal spray (BA)
Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA).
干预措施: diazepam nasal spray (Drug)
结局指标
主要结局
Maximum measured plasma concentration (Cmax)
时间窗: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24)
时间窗: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Apparent total body clearance of drug from plasma (CL/F)
时间窗: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to infinity (AUCinf)
时间窗: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
次要结局
- Number of patients with adverse events (AEs) including serious AEs(up to 21 days)
- Change in focused nasal exam(within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose)
- Taste change questionnaire(from 5 minutes up to 24 hours post-dose)