Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Plasma Concentration analysis
研究概览
简要总结
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
详细描述
Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
esomeprazole
esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
干预措施: esomeprazole (Drug)
结局指标
主要结局
Plasma Concentration analysis
时间窗: It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose
The pharmacokinetic parameters for esomeprazole and its main metabolites
次要结局
- CYP2C19 genotypes analysis(The genotype will be assessed on Day 1)