Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil® (200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable time point)
研究概览
简要总结
The objective of the current study is to demonstrate bioequivalence of a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg (Test) and RhinAdvil® (Reference) a fixed dose combination tablet containing ibuprofen 200 mg and pseudoephedrine-HCl 30 mg following orally administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（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
Pseudoephedrine-HCl 30 mg
Oral administration as a fixed dose combination tablet (RhinAdvil(R))
干预措施: Pseudoephedrine-HCl (Drug)
Ibuprofen 200 mg
Oral administration as a fixed dose combination tablet (RhinAdvil(R))
干预措施: Ibuprofen (Drug)
Ibuprofen 200 mg BI
Oral administration as a fixed dose combination tablet (BI product)
干预措施: Ibuprofen (Drug)
Pseudoephedrine-HCl 30 mg BI
Oral administration as a fixed dose combination tablet (BI product)
干预措施: Pseudoephedrine-HCl (Drug)
结局指标
主要结局
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable time point)
时间窗: 1 month
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: 1 month
次要结局
- AUC0-* (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (*=infinity)(1 month)