NCT01046162撤回1 期
An Open Label,Crossover,Randomized Study Of Two Periods,Two Treatments,Two Sequences, And A Single Dose Of Two Oral Drug Products Of Alprazolam 2mg (Tafil (r), Product Of Pharmacia& Upjohn S.a De C.v Vs Xanax 2mg, Product Of Pfizer Pharmaceuticals Llc) In Healthy Volunteers In Fasting Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2010年7月15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
- 撤回
- 发起方
- 主要终点
- Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam.
研究概览
简要总结
The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers (male or female)
- •Age between 18-40 years
- •body mass index (Quetelet´s index) between 18-27
排除标准
- •Unhealthy subjects
- •Volunteers who require any medication over the course of the study
- •Volunteers who have received investigational drugs within 60 days prior to the study
研究组 & 干预措施
Tafil Tablets 2 mg Pharmacia Upjohn
Active Comparator
干预措施: Alprazolam (Drug)
Xanax Tablets 2 mg Pfizer LLC
Active Comparator
干预措施: Alprazolam (Drug)
结局指标
主要结局
Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam.
时间窗: 10 days
Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence.
时间窗: 10 days
次要结局
- Investigate the safety of both preparations based on the record of adverse events on completing both study periods.(10 days)
研究者
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撤回
1 期
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet FormulationHealthyNCT01027689Pfizer's Upjohn has merged with Mylan to form Viatris Inc.