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临床试验/NCT00965978
NCT00965978已完成1 期

A Study to Evaluate Food Effect on Pharmacokinetics Parameters After Administration of ONO-5920/YM529 Intermittent Formulation

Astellas Pharma Inc0 个研究点目标入组 48 人开始时间: 2009年7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
48
主要终点
Pharmacokinetic parameter of ONO-5920/YM529
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记录与标识符相似试验

研究概览

简要总结

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

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
None

入排标准

年龄范围
45 Years 至 81 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Post menopausal women (at least 2 years after menopause)
  • •Body weight: more than 40.0 Kg and less than 70.0 Kg
  • •BMI: more than 17.6 and less than 30.0

排除标准

  • •Receives investigational drug within 120 day before the study
  • •Blood donation before the study
  • •With abnormal laboratory values

研究组 & 干预措施

Low dose group

Experimental

Receives low dose of ONO-5920/YM529 with and without food

干预措施: ONO-5920 / YM529 (Drug)

High dose group

Experimental

Receives high dose of ONO-5920/YM529 with and without food

干预措施: ONO-5920 / YM529 (Drug)

结局指标

主要结局

Pharmacokinetic parameter of ONO-5920/YM529

时间窗: For 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Industry

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