NCT00939562已完成4 期
An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Doxycycline
研究概览
简要总结
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 and 55 years.
- •Body Mass Index (BMI) of 18 to 30 kg/m2.
排除标准
- •Evidence or history of clinically significant abnormality.
- •Any condition possibly affecting drug absorption.
- •A positive urine drug screen.
研究组 & 干预措施
doxycycline monohydrate tablet
Experimental
干预措施: doxycycline monohydrate tablet (Drug)
doxycycline carragenate tablet
Active Comparator
干预措施: doxycycline carragenate tablet (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Doxycycline
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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