NCT00688428已完成1 期
A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 84
- 主要终点
- Samples for measurement of esomeprazole, ASA, and SA concentrations
研究概览
简要总结
The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet
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
- •Body mass index of 19-29kg/m2, inclusive
- •Weight of 50-95kg, inclusive
- •Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator
排除标准
- •Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
- •History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
- •Condition which could modify the absorption of the investigational products, as judged by the Investigator
研究组 & 干预措施
1
Experimental
combination capsule of Esomeprazole 40mg + ASA 325mg
干预措施: Esomeprazole 40mg/ASA 325mg (Drug)
2
Experimental
Esomeprazole 40 mg capsule and ASA 325 mg tablet
干预措施: Esomeprazole (Drug)
2
Experimental
Esomeprazole 40 mg capsule and ASA 325 mg tablet
干预措施: ASA (Drug)
结局指标
主要结局
Samples for measurement of esomeprazole, ASA, and SA concentrations
时间窗: Day 1 of each period
次要结局
- Fasting blood samples for determination of clinical chemistry and hematology parameters(screening and follow up visit)
- urine samples for urinalysis parameters(screening, Period 1, and follow-up visit)
研究者
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