NCT01421043已完成1 期
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Triazolam Liquid Oral Drops at a Dose of 0.25 Mg Versus Triazolam 0.25 Mg Tablet in Healthy Subjects
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
- Pfizer
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) to last time point (t)
研究概览
简要总结
This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.
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 and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
研究组 & 干预措施
triazolam liquid oral drops
Experimental
干预措施: triazolam liquid oral drops (Drug)
triazolam tablets
Active Comparator
干预措施: triazolam tablets (Drug)
结局指标
主要结局
Area Under the Curve (AUC) to last time point (t)
时间窗: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Maximum concentration of drug (Cmax)
时间窗: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
次要结局
- Half-life (if data permit)(0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose)
- Time at maximum concentration (Tmax)(0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose)
- Area Under the Curve (AUC) to time infinity (inf) (if data permit)(0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose)
- Area Under the Curve (AUC) percent extrapolated (%exp)(0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Relative Bioavailability and Food Effect Study of CVN424Parkinson's DiseaseNCT05635461Cerevance Beta, Inc.32
已完成
1 期
Food and Relative Bioavailability StudyDepressive DisorderNCT00843011GlaxoSmithKline14
已完成
1 期
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting ConditionsHealthyNCT01164787Dr. Reddy's Laboratories Limited52
已完成
1 期
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed ConditionsHealthyNCT01164800Dr. Reddy's Laboratories Limited52
撤回
1 期
Bioequivalence of a New and a Commercial Alprazolam Sublingual FormulationHealthyNCT01285505Pfizer's Upjohn has merged with Mylan to form Viatris Inc.