适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 30
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
1
Experimental
Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)
干预措施: Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals) (Drug)
2
Active Comparator
Alprazolam Tablets, 1 mg (The Upjohn Company)
干预措施: Alprazolam Tablets, 1 mg (The Upjohn Company) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 13 days
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mgAnxietyNCT00912145Sandoz26
已完成
1 期
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting ConditionsHealthyNCT01188057Actavis Inc.40
已完成
1 期
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting ConditionsHealthyNCT01188031Actavis Inc.40
已完成
1 期
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting ConditionsHealthyNCT00830024Teva Pharmaceuticals USA36
已完成
1 期
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting ConditionsHealthyNCT00829426Teva Pharmaceuticals USA32