NCT02249936已完成1 期
A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole
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
- Ardelyx
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy man or woman
- •Body mass index between 18 and 29.9 kg/m2
排除标准
- •Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
- •Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk
研究组 & 干预措施
AZD1722 HCl Capsule
Experimental
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
干预措施: AZD1722 (Drug)
AZD1722 HCl Capsule
Experimental
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
干预措施: Omeprazole (Drug)
AZD1722 HCl Tablet
Experimental
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
干预措施: AZD1722 (Drug)
AZD1722 HCl Tablet
Experimental
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
干预措施: Omeprazole (Drug)
AZD1722 Free-base Tablet
Experimental
15 mg bid AZD1722 and 20 mg bid Omeprazole
干预措施: AZD1722 (Drug)
AZD1722 Free-base Tablet
Experimental
15 mg bid AZD1722 and 20 mg bid Omeprazole
干预措施: Omeprazole (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: 8 days
Measurement of safety laboratories, ECGs, vitals signs and physical exams
次要结局
- Sodium levels in stool and urine(8 days)
- Plasma drug concentration to calculate AUC(8 days)
研究者
研究点 (1)
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