Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non smoking
- •Ages 18 to 45 year, inclusive
- •BMI between 18 and 30
排除标准
- •Subjects taking any prescription or OTC medications or vitamins or supplements
- •Pregnant females
- •Subjects with pulmonary disease or sleep apnea
研究组 & 干预措施
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg
Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
干预措施: Single dose of SUF NT 15 mcg (Drug)
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg
Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
干预措施: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes (Drug)
结局指标
主要结局
Cmax
时间窗: 24 hours in Treatment A, 37 hours in Treatment B
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
CST½
时间窗: 24
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Time to Steady State
时间窗: 24 hours
Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p \>0.05)
次要结局
未报告次要终点