NCT00877955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 Sublingual Tablet
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2012年9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 sublingual formulation expected to be used commercially in Brazil.
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 sublingual tablet reference
Active Comparator
干预措施: alprazolam sublingual tablet commercial (Drug)
alprazolam sublingual tablet test
Experimental
干预措施: alprazolam sublingual tablet test (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
相似试验
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.
已完成
1 期
Bioequivalence of Alprazolam Sublingual vs Oral TabletsHealthyNCT00860119Pfizer's Upjohn has merged with Mylan to form Viatris Inc.23
撤回
1 期
Bioequivalence of a New and a Commercial Alprazolam Sublingual FormulationHealthyNCT01285505Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
已完成
1 期
A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study ParticipantsHealthy ParticipantsNCT05626439UCB Biopharma SRL21
撤回
1 期
A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting ConditionsHealthyNCT01046162Pfizer's Upjohn has merged with Mylan to form Viatris Inc.