A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations
研究概览
简要总结
The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) 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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking male or female within the age range of 20 to 50 years
- •Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2
排除标准
- •Documented upper gastrointestinal surgery
- •Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit
研究组 & 干预措施
1
Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule
干预措施: Esomeprazole/ASA Fixed Combination (Drug)
2
Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
干预措施: Esomeprazole - Nexium (Drug)
2
Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
干预措施: ASA (Drug)
3
Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
干预措施: Esomeprazole - Nexium (Drug)
3
Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
干预措施: ASA (Drug)
结局指标
主要结局
Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations
时间窗: PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III.
次要结局
- Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole(PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm)