NCT00563732已完成1 期
An Open-Label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Lecozotan SR and a Single Oral Dose of Digoxin When Administered Orally to Healthy Adult Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2007年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 主要终点
- Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
研究概览
简要总结
Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects.
Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and digoxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Women of non childbearing potential and men aged 18 to 55 years at screening.
- •Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight 50 kg (BMI = weight (kg)/[height (m)]
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.
结局指标
主要结局
Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Effect of Ketoconazole on Regorafenib (BAY73-4506) PharmacokineticsPharmacokineticsNCT01318265Bayer24
已完成
1 期
A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy ParticipantsHealthy ParticipantsNCT04453189Janssen Research & Development, LLC14
已完成
1 期
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy SubjectsAlzheimer DiseaseNCT00494962Wyeth is now a wholly owned subsidiary of Pfizer40
终止
1 期
A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult ParticipantsHealthyNCT03468777Janssen Research & Development, LLC18
已完成
1 期
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic ImpairmentHealthy VolunteersHepatic ImpairmentNCT03983161Celgene39