A Randomized, Single-dose, Two-way Cross-over Study to Assess the Bioequivalence of Lendormin Tablets 0.25 mg (Delpharm Reims) vs. Lendormin Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) Administered to Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule
研究概览
简要总结
The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 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
Brotizolam tablet
Brotizolam tablets 250mcg : at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively
干预措施: Brotizolam tablet (Drug)
Lendormin tablet
Lendormin tablets 250mcg: at least 6 and 24 subjects will be enrolled in the pre-study and main study, respectively
干预措施: Lendormin tablet (Drug)
结局指标
主要结局
AUC 0-t: Area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the traperoidal rule
时间窗: One month
T 1/2: Plasma half-life estimated by (0.693/kel)
时间窗: One month
MRT : Mean residence time
时间窗: One month
Tmax:Time to peak drug concentration obtained directly from the data without interpolation
时间窗: One month
AUMC : Area under the ( first) moment plasma concentration - time curve
时间窗: One month
AUC 0- : Area under the plasma concentration-time curve from time zero to infinity determined by the trapezoidal rule and extrapolated to infinity estimated by the last quantifiable concentration (Cn) divided by kel
时间窗: One month
Cmax: Peak drug concentration obtained directly from the data without interpolation
时间窗: One month
kel:Plasma elimination rate constant determined by simple linear regression based on the terminal phase of plasma concentration
时间窗: One month
次要结局
- heart rate(one month)
- body temperature(One month)
- 12 Laed ECG, Lab Test ( Hematocrit, WBC count with differential, RBC count and platelet count ; SGOT ( AST), SGPT (ALT) , alkaline phosphatase, total bilirubin, albumin, glucose, BUN, creatinine,uric acid, total cholesterol and TG)(One month)
- Blood pressure(one month)