NCT01886469已完成1 期
A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.
Ironshore Pharmaceuticals and Development, Inc1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
研究概览
简要总结
The main purpose of this study is to determine the rate and extent of absorption of one or more modified release formulations of amphetamine (HLD100) in both adolescents and children with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Adolescents (12-17yrs)
Experimental
干预措施: HLD100-B (Drug)
Adolescents (12-17yrs)
Experimental
干预措施: HLD100-C (Drug)
Adolescents (12-17yrs)
Experimental
干预措施: HLD100-E (Drug)
Children (6-11 yrs)
Experimental
干预措施: HLD100-B (Drug)
Children (6-11 yrs)
Experimental
干预措施: HLD100-C (Drug)
Children (6-11 yrs)
Experimental
干预措施: HLD100-E (Drug)
结局指标
主要结局
Rate and Extent of absorption of d-amphetamine (AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim)
时间窗: 48hrs
次要结局
- Safety (AEs, ECG, laboratory parameters, physical examinations)(48 hours)
研究者
研究点 (1)
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