A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Cmax
研究概览
简要总结
A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
- •BMI must be within the range 18.5 - 24.9 kg/m^2
- •Participant with a minimum weight of 50 kg
排除标准
- •Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
- •Participant with known or suspected intolerance or hypersensitivity to the study materials
- •Participant who are vegetarian
- •Participant smoking more than five cigarettes a day
研究组 & 干预措施
Experimental Paracetamol Tablet
Experimental paracetamol tablet (500 milligrams [mg]) administered with 240 milliliters (mL) of water.
干预措施: Paracetamol (Drug)
Standard Paracetamol Tablet (500 mg)
Standard paracetamol tablet (500 mg) administered with 240 mL of water.
干预措施: Paracetamol (Drug)
结局指标
主要结局
Cmax
时间窗: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Maximum plasma concentration of paracetamol.
AUC (0-t)
时间窗: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample.
AUC (0-inf)
时间窗: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Area under the plasma concentration time curve from zero and extrapolated to infinite time.
次要结局
- Tmax(Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.)