NCT02336347已完成1 期
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
Otsuka Pharmaceutical Development & Commercialization, Inc.2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2014年5月1日最近更新:
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
- 62
- 试验地点
- 2
- 主要终点
- PK of d6-DM in AVP-786 compared to DM in AVP-923
研究概览
简要总结
To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males or females
- •18 - 60 years of age
- •BMI 18 - 32 kg/m2
排除标准
- •History or presence of significant disease
- •History of substance abuse and/or alcohol abuse with the past 2 years
- •Use of tobacco-containing or nicotine-containing products within 6 months
- •Use of any prescription or the over-the-counter medications within 14 days
研究组 & 干预措施
Group 1 - Period 2
Active Comparator
Twice daily dosing of AVP-923 orally for 8 days
干预措施: AVP-923 (Drug)
Group 2 - Period 1
Active Comparator
Twice daily dosing of AVP-923 orally for 8 days
干预措施: AVP-923 (Drug)
Group 2 - Period 2
Experimental
Twice daily dosing of AVP-786 orally for 8 days
干预措施: AVP-786 (Drug)
Group 1 - Period 1
Experimental
Twice daily dosing of AVP-786 orally for 8 days
干预措施: AVP-786 (Drug)
结局指标
主要结局
PK of d6-DM in AVP-786 compared to DM in AVP-923
时间窗: 8 days
次要结局
- PK of metabolites(8 days)
- Safety and tolerability(8 days)
研究者
研究点 (2)
Loading locations...
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