NCT02618395已完成1 期
Bioavailability Study of SPARC001 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
研究概览
简要总结
Bioavailability study
详细描述
Bioavailability, safety and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, male and female volunteers, 18 to 55 years of age
- •Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
- •Female subjects must have a negative serum pregnancy test
- •Medically healthy on the basis of medical history and physical examination
排除标准
- •Females who are pregnant, lactating, or likely to become pregnant during the study
- •Life-time history and/or recent evidence of alcohol
- •History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
- •Subjects with any condition in which an opioid is contraindicated
研究组 & 干预措施
Treatment A
Experimental
干预措施: SPARC001A (Drug)
Treatment B
Experimental
干预措施: SPARC001B (Drug)
Treatment C
Experimental
干预措施: Reference001 - Hydrocodone (Drug)
结局指标
主要结局
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
时间窗: 17 days
次要结局
- Treatment emergent adverse event(17 days)
- AUC extrapolated to infinity (AUC0 ∞)(17 days)
- Elimination half-life (t½)(17 days)
- Time to Cmax (tmax)(17 days)
研究者
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