An Open-label, Single Treatment, Single Period, Single Buccal Dose Pharmacokinetic Study of Paracetamol Uniflash (125 mg/ 1.25 mL) in Healthy, Adult, Human Subjects Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Paracetamol Peak Plasma Concentration (Cmax) After Single Dose
研究概览
简要总结
This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and non-pregnant female human subjects, age 18 - 45 years.
- •Body Mass Index between 18.5-30 Kg / m2 .
- •Subjects with normal findings .
- •Willingness to follow the protocol requirements
排除标准
- •History of allergy or hypersensitivity intolerance to paracetamol and ethanol
- •Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
- •Lactating or nursing female subjects;
- •History of difficulty in accessibility of veins in arms.
研究组 & 干预措施
paracetamol Uniflash (125 mg/ 1.25 mL)
1 sachet of paracetamol Uniflash 125mg / 1.25 mL
干预措施: paracetamol Uniflash (125 mg/ 1.25 mL) (Drug)
结局指标
主要结局
Paracetamol Peak Plasma Concentration (Cmax) After Single Dose
时间窗: Up to 12 hours post dose
Peak Plasma Concentration (Cmax) of paracetamol after single dose at different timepoints : Within 60 min before drug administration), at 1 min, 5 min, 10 min, 15 min, 20 min, 40 min, 1h, 2h, 4h, 6h, 8h, 10h and 12h post-dose
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose
时间窗: Up to 12 hours post dose
Area under the plasma concentration versus time curve (AUC) of paracetamol after single dose at different timepoints :Within 60 min before drug administration), at 1 min, 5 min, 10 min, 15 min, 20 min, 40 min, 1h, 2h, 4h, 6h, 8h, 10h and 12h post-dose
次要结局
- Number of Treatment-related Adverse Events(Up to 12 hours)