Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.
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
- •body mass index 18 - 30
排除标准
- •pregnant females
- •pulmonary disease
- •sleep apnea
研究组 & 干预措施
Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 1 - Treatment A, B, C, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 2 - Treatment A, B, D, C
15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 3 - Treatment A, C, B, D
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 4 - Treatment A, C, D, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 5 - Treatment A, D, B, C
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
干预措施: Treatment A: Sufentanil IV (Drug)
Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
干预措施: Treatment B: Sufentanil NanoTab Sublingual (Drug)
Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
干预措施: Treatment C: Sufentanil NanoTab Buccal (Drug)
Sequence 6 - Treatment A, D, C, B
15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
干预措施: Treatment D: Sufentanil NanoTab Oral (Drug)
结局指标
主要结局
Tmax
时间窗: 24 hours
time to maximum plasma concentration
AUC (0 - Inf)
时间窗: 24 hours
total amount of sufentanil absorbed
Cmax
时间窗: 24 hours
maximum plasma concentration
CST 1/2
时间窗: 24 hours
time for maximum plasma concentration to decrease by 50%
次要结局
未报告次要终点