A Phase I, Open-label, Randomized, Two Way Crossover Pharmacokinetic Study Comparing the Bioavailability of Acetylsalicylic Acid (ASA) After 5 Days Repeated Once Daily Administration of a Fixed Dose Combination Capsule of ASA 81 mg/Esomeprazole 20 mg and ASA 80 mg (European Aspirin Reference Product)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2).
研究概览
简要总结
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.
详细描述
A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 20 to 50 years inclusive.
- •Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
- •Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study.
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
- •History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
研究组 & 干预措施
1
Capsule ASA 81mg/esomeprazole 20mg
干预措施: Capsule ASA 81mg/esomeprazole 20mg (Drug)
2
ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg
干预措施: Acetylsalicylzuur Apotex Cardio (Drug)
结局指标
主要结局
pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2).
时间窗: Day 5
PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.
次要结局
- Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs(Pre-dose up to 7 day after last dose)