A Phase I, Open Label, Randomized, Single Center, 2 Way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
研究概览
简要总结
The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.
详细描述
A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese males 20-45 years of age
- •Classified as homo-EM
- •Negative for HIV, Hepatitis B, Hepatitis C and syphilis
- •Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
- •Body weight 50-85 kg
排除标准
- •Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- •Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- •Need for concomitant medication in the study
- •Past or present NSAIDs induced asthma
- •History of bleeding diathesis
研究组 & 干预措施
esomeprazole + buffered acetylsalicylic acid
2 way crossover
干预措施: Buffered acetylsalicylic acid (Drug)
D961S
2 way crossover
干预措施: D961S (Drug)
esomeprazole + buffered acetylsalicylic acid
2 way crossover
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
时间窗: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)
时间窗: Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.
次要结局
- Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.(Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose))
- Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA(Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6)