Randomized, 2-way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets and AUGMENTIN® 400 Mg-57 mg Chewable Tablets Administered as 1 x 400 Mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under fasting conditions.
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
Amoxicillin Clavulanic Acid
Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 400-57 mg Chewable Tablet (reference) dosed in second period
干预措施: amoxicillin-clavulanic acid (Drug)
Augmentin®
Augmentin® 400-57 mg Chewable Tablet (reference) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in second period
干预措施: Augmentin® (Drug)
结局指标
主要结局
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
时间窗: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-t
AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
时间窗: Blood samples were collected over 10 hour period
Bioequivalence based on AUC0-inf
Cmax (Maximum Observed Concentration) - Clavulanic Acid
时间窗: Blood samples collected over 10 hour period
Bioequivalence based on Cmax
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid
时间窗: Blood samples collected over 10 hour period
Bioequivalence based on AUC0-inf
Cmax (Maximum Observed Concentration) - Amoxicillin
时间窗: Blood samples were collected over 10 hour period
Bioequivalence based on Cmax
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
时间窗: Blood samples were collected over 10 hour period
Bioequivalence based on AUC0-t
次要结局
未报告次要终点