NCT01302158已完成1 期
An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride
研究概览
简要总结
A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).
详细描述
Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 30 kg/m2, inclusive
排除标准
- •Any of the liver function tests above the upper limit of normal
- •Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg
结局指标
主要结局
Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride
时间窗: 14 days
次要结局
- Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug to Drug Interaction Study With ASP1941 and MetforminType 2 Diabetes MellitusNCT01302145Astellas Pharma Inc36
已完成
1 期
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese SubjectsHealthyPharmacokinetics of ASP1941NCT01373060Astellas Pharma Inc56
已完成
1 期
Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy AdultsHealthy VolunteersPharmacokinetics of ASP1941NCT01678287Astellas Pharma Global Development, Inc.65
已完成
1 期
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy SubjectsPharmacokinetics of ASP1941Healthy VolunteerNCT01121198Astellas Pharma Inc84
已完成
1 期
Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid TumorsLocally Advanced (Unresectable) or Metastatic Solid Tumor MalignanciesNCT04094506Astellas Pharma Inc9