NCT00860119已完成1 期
Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2009年8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
- 23
- 试验地点
- 1
- 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 a standard orally administered tablet.
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
- 21 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
Sublingual tablet
Experimental
Test treatment
干预措施: alprazolam sublingual tablet (Drug)
Oral tablet
Experimental
Reference treatment
干预措施: alprazolam oral 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
- Adverse events, clinical laboratory tests, vital signs(11 days)
- Alprazolam time of maximum concentration (Tmax) and half life(11 days)
研究者
研究点 (1)
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