A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5mL Oral Suspension Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax = Maximum Observed Concentration.
研究概览
简要总结
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast meal began 30 minutes prior to each dose.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Doxycycline Monohydrate
干预措施: Doxycycline Monohydrate (Drug)
2
Vibramycin Monohydrate®
干预措施: Doxycycline Monohydrate (Drug)
结局指标
主要结局
Cmax = Maximum Observed Concentration.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on Cmax.
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点