NCT01330472已完成1 期
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
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 16 人开始时间: 2011年5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
- 16
- 试验地点
- 1
- 主要终点
- Area under the curve from time zero to infinity (AUCinf) of alprazolam
研究概览
简要总结
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive.
- •An informed consent document signed and dated by the subject.
排除标准
- •Evidence or history of clinically significant abnormality.
- •A positive urine drug screen.
- •Subjects who are hypersensitive to alprazolam or related compounds.
研究组 & 干预措施
Xanax XR tablets 3 mg (sourced from Caugus)
Active Comparator
Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
干预措施: Xanax XR tablets 3 mg (sourced from Caugus) (Drug)
Xanax XR tablets 3 mg (sourced from Barceloneta),
Experimental
Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)
干预措施: Xanax XR tablets 3 mg (sourced from Barceloneta) (Drug)
结局指标
主要结局
Area under the curve from time zero to infinity (AUCinf) of alprazolam
时间窗: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Peak plasma conc (Cmax) of alprazolam
时间窗: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
次要结局
- Area under the curve extrapolated (AUC%extrap) of alprazolam(Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose)
- Area under the curve from zero to the last time point (AUClast) of alprazolam(Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose)
- Terminal half life of alprazolam(Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose)
- Time to peak concentration (Tmax) of alprazolam(Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose)
研究者
研究点 (1)
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