Relative Bioavailability Study of Amlodipine Powder for Oral Solution, 5 mg (Base) Under Fasting and Fed Conditions
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
- AUC0-inf
研究概览
简要总结
The goal of this clinical study is to assess the relative bioavailability of Amlodipine for Oral Solution 5 mg of Brillian Pharma Inc. under fasting and fed conditions versus reference product Norvasc 5 mg tablets of Pfizer Labs under fasting in normal, healthy, adult, male,
Primary Objective:
- To compare the relative bioavailability.
- To assess the food effect in Test product (T1) (Fast) vs Test product (T2) (Fed) Amlodipine Oral Solution 5 mg of Brillian Pharma Inc.
Secondary Objective:
To monitor the safety and tolerability of a single oral dose of investigational medicinal products (IMPs).
详细描述
A total of 24 healthy, adult, male and female human volunteers will be enrolled.
Excluding the screening period, the duration of the clinical phase will be approximately 50 days including a washout period of at least 21 days for each study period.
This study is being conducted in healthy, adult, human subjects under fasting and fed conditions as per USFDA and NMPA guidelines. The present study will be conducted to assess the relative bioavailability of the test product versus the reference product under fasting conditions. The study also assesses the effect of food on the bioavailability of Amlodipine FD-POS 5 mg (Powder in a Unit-dose container) product.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, Healthy
排除标准
- 未提供
研究组 & 干预措施
T1 Fasting
Giving test product under fasting condition
干预措施: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg (Drug)
T2 Fed
Giving test product under fed condition
干预措施: Amlodipine Freeze-Dried Powder for Oral Solution 5 mg (Drug)
R Fasting
Giving reference product under fasting condition
干预措施: Norvasc 5 mg tablets of Pfizer Labs (Drug)
结局指标
主要结局
AUC0-inf
时间窗: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
AUC0-t plus additional area extrapolated to infinity, calculated using the formula AUC0-t + Ct/Kel , where Ct is the last measurable drug concentration and Kel is the elimination rate constant.
AUC0-t
时间窗: 50 days
Area under the plasma concentration-time curve measured to the last quantifiable concentration, using the linear trapezoidal rule.
Cmax
时间窗: 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose
Maximum observed drug concentration during the study
次要结局
- Tmax(6 days)
- t1/2(6 days)
- Residual Area(1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose)
- Kel(6 days)
- AUC0-t/AUC0-inf(1, 2, 3, 4, 5,6, 7, 8, 9, 10, 12, 14, 16, 20, 24, 48, 60, 72, 96, 120, 144 hours post dose)