Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg 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
- 2
- 主要终点
- Area Under the Curve
研究概览
简要总结
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 male or female subjects
- •Aged between 18 and 45 years inclusive
- •Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.
排除标准
- •Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
- •Female subjects who are pregnant
- •Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
研究组 & 干预措施
Treatment A
Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute
干预措施: Treatment Arm A: Sufenta® (Drug)
Treatment B
Single dose of SSM 30 mcg
干预措施: Treatment B: Sufentanil SSM 30 mcg (Drug)
Treatment C
2 consecutive doses of SSM 15 mcg administered 20 minute apart
干预措施: Treatment C: SSM 15 mcg (Drug)
Treatment D
12 consecutive doses of SSM 30 mcg administered 1 hour apart
干预措施: Treatment D: SSM 30 mcg (Drug)
结局指标
主要结局
Area Under the Curve
时间窗: 9 days, not including a 30 day screening window
Area under the plasma concentration time curve
次要结局
未报告次要终点