NCT01159145已完成1 期
A Randomised, Single Blind, Two-way Cross-over, Single-centre Study to Assess the Pharmacodynamics (Intragastric pH) and Pharmacokinetics After Repeated Oral Administration of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects
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
- 42
- 试验地点
- 1
- 主要终点
- To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.
研究概览
简要总结
The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who are classified by the genotype of CYP2C19 by the assessment of percentage of time with intragastric pH>4 during 24 hours after dose on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
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 male subjects between 20 and 45 years of age
- •Genotype of CYP2C19 has been known as the volunteer panel data
- •H. pylori negative has been known by urea breath test as the volunteer panel data.
排除标准
- •Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s), eg, acute inflammatory disease which requires medical intervention
- •Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
- •Past or present severe allergic disease, hypersensitivity to food or drugs (except for seasonal hay fever), or allergic symptoms requiring medical intervention (eg, anesthetics used at the intragastric pH measurement)
研究组 & 干预措施
D961H 10 mg capsule
Experimental
2 way crossover
干预措施: D961H (Drug)
Omeprazole 10 mg tablet
Experimental
2 way crossover
干预措施: Omeprazole (Drug)
结局指标
主要结局
To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects by the assessment of percentage of time with intragastric pH>4.
时间窗: A range of 24 hrs
次要结局
- To assess the pharmacodynamics (intragastric pH) after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of percentage of time with intragastric pH>3 during 24 hours and 24-hour median intragastric pH.(A range of 24 hrs)
- To assess the pharmacokinetics after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of plasma concentrations and AUCt, AUCt, Css,max, tmax, and t1/2 for D961H and omeprazole after dose on day 5.(A range of 24 hours)
- To assess the safety and the tolerability after repeated administration of D961H 10 mg and omeprazole 10 mg by the assessment of adverse events, laboratory variables, pulse rate, blood pressure, body temperature and 12-lead ECG(Until last visit, 5-7 days after last dose)
研究者
研究点 (1)
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