NCT01027689撤回1 期
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2011年4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
- 撤回
- 发起方
- 主要终点
- Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
研究概览
简要总结
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects
- •BMI 17.5 - 30.5
- •Must provide informed consent
排除标准
- •Clinically significant disease
- •Narrow angle glaucoma
- •Positive drug screen
研究组 & 干预措施
Alprazolam commercial immediate release oral tablet
Active Comparator
干预措施: alprazolam commercial immediate release oral tablet (Drug)
Alprazolam test sublingual tablet
Experimental
干预措施: alprazolam test sublingual tablet (Drug)
结局指标
主要结局
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
时间窗: 11 days
次要结局
- Alprazolam time of maximum concentration (Tmax) and half life(11 days)
- Adverse events, clinical laboratory tests, vital signs(11 days)
研究者
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