NCT02174835已完成1 期
A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
Otsuka Pharmaceutical Development & Commercialization, Inc.2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年9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
- 56
- 试验地点
- 2
- 主要终点
- Plasma concentrations of AVP-786
研究概览
简要总结
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males
- •18 - 45 years of age
- •BMI 18 - 30 kg/m2
排除标准
- •History or presence of significant disease
- •History of substance abuse and/or alcohol abuse with the past 3 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
Cohort A - Period 1
Experimental
Twice daily dosing orally for 7 days
干预措施: AVP-786 (Drug)
Cohort A - Period 2
Active Comparator
Twice daily dosing orally for 7 days
干预措施: AVP-923 (Drug)
Cohort A - Period 3
Experimental
Twice daily dosing orally for 7 days
干预措施: AVP-786 (Drug)
Cohort B - Period 1
Experimental
Twice daily dosing orally for 7 days
干预措施: AVP-786 (Drug)
Cohort B - Period 2
Active Comparator
Twice daily dosing orally for 7 days
干预措施: AVP-923 (Drug)
Cohort B - Period 3
Experimental
Twice daily dosing orally for 7 days
干预措施: AVP-786 (Drug)
结局指标
主要结局
Plasma concentrations of AVP-786
时间窗: 7 days
次要结局
- Incidence of adverse events (AEs) for AVP-786(7 days)
研究者
研究点 (2)
Loading locations...
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