A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
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
- •Meets protocol-specified criteria for qualification and contraception
- •Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
排除标准
- •Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff;
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- •the analysis of results
研究组 & 干预措施
Test-Reference Sequence
SL spray, followed by SL film
干预措施: SL spray (Drug)
Test-Reference Sequence
SL spray, followed by SL film
干预措施: SL film (Drug)
Reference-Test Sequence
SL film followed by SL spray
干预措施: SL spray (Drug)
Reference-Test Sequence
SL film followed by SL spray
干预措施: SL film (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time to Cmax (Tmax)
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination rate constant
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination half-life (T½)
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Area under the curve extrapolated to infinity (AUCinf)
时间窗: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
次要结局
未报告次要终点