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临床试验/NCT01148368
NCT01148368已完成1 期

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

Boryung Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年6月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
pharmacokinetic characteristic of fimasartan
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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
是

入选标准

  • •<Renal impairment patient>
  • •age: 20-65 years
  • •eGFR: < 30ml/min/1.73m^2
  • •not on dialysis
  • •body weight: greater than 55kg
  • •written informed consent
  • •<Healthy volunteer>
  • •age: 20-65 years
  • •body weight: greater than 55kg
  • •written informed consent

排除标准

  • •AST, ALT > 1.5 times of upper normal range
  • •positive drug or alcohol screening

研究组 & 干预措施

renal impairment patients

Experimental

renal impairment patients who eGFR is lower than 30 ml/min/1.73m^2 without hemodialysis

干预措施: fimasartan (Drug)

healthy volunteers

Active Comparator

healthy volunteers group

干预措施: fimasartan (Drug)

结局指标

主要结局

pharmacokinetic characteristic of fimasartan

时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h

AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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