A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
研究概览
简要总结
The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 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
Test Product
Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
干预措施: Ascorbic Acid (Drug)
Test Product
Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
干预措施: Paracetamol (Drug)
Test Product
Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
干预措施: Phenylephrine (Drug)
Paracetamol tablet
Two paracetamol 500 mg tablets to be administered with 150 mL of hot water.
干预措施: Paracetamol (Drug)
结局指标
主要结局
Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
时间窗: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.
次要结局
- Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)(Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose)
- AUC (0-60 Min)(Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose)
- Maximum Plasma Concentration (Cmax)(Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose)
- Time to Maximum Plasma Concentration (Tmax)(Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose)
- Time to Onset of Gastric Emptying(Baseline to 10 hours)
- Time to Completion of Gastric Emptying(Baseline to 10 hours)
- Time to Onset and Completion of Disintegration of Reference Tablets(Baseline to 10 hours post dose)