A Proof of Principal Study to Investigate the Pharmacokinetic Profiles of Sustained Release and Standard Paracetamol Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Median time to reach therapeutic plasma concentration of paracetamol
研究概览
简要总结
This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.
排除标准
- •Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
- •Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
研究组 & 干预措施
Test Sustained Release (SR) Paracetamol (2000 mg)
A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water.
干预措施: Paracetamol 1000 mg (Drug)
Test SR Paracetamol (1500 mg)
A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water.
干预措施: Paracetamol 750 mg (Drug)
Reference Paracetamol (2000 mg)
Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water.
干预措施: Paracetamol 500 mg (Drug)
结局指标
主要结局
Median time to reach therapeutic plasma concentration of paracetamol
时间窗: Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment
Time period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (μg)/milliliter (mL).
次要结局
- Area under the plasma concentration-time curve (AUC)(Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment)
- Time to maximum plasma concentration (Tmax)(Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment)
- Half-life of elimination (T 1/2)(Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment)
- Elimination rate (Kel)(Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment)
- Maximum plasma concentration (Cmax)(Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment)
- Number of participants with Adverse Events (AEs) and Serious AEs(Day 1 through Day 14 (follow-up visit))