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临床试验/jRCT2080224678
jRCT2080224678已完成1 期

A Phase 1, Open-Label, Randomized, Three-Period, Crossover Study to Evaluate the Relative Bioavailability of Naldemedine Granule to Tablet and the Effect of Food on the Pharmacokinetics of Naldemedine in Healthy Adult Subjects

SHIONOGI & CO., LTD.1 个研究点目标入组 18 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
入组人数
18
试验地点
1
主要终点
maximum plasma concentration
研究概览研究设计入排标准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

暂无简介。

研究设计

研究类型
Interventional
干预模型
Crossover and open-label study
主要目的
Treatment Purpose

入排标准

年龄范围
20age old over 至 55age old under（—）
性别
All

入选标准

  • •Healthy Caucasian adult subjects between the ages >=20 and <=55

排除标准

  • •Subjects who are considered by the investigator or subinvestigator to be unsuitable for participation in the study for any reason.

结局指标

主要结局

maximum plasma concentration

Cmax

time to maximum plasma concentration

Tmax

area under the concentration-time curve from time zero to the time of the last quantifiable concentration

AUC0-last

area under the concentration-time curve extrapolated from time zero to infinity

AUC0-inf

terminal elimination rate constant

lambdaz

terminal elimination half-life

t1/2,z

mean residence time

MRT

apparent total clearance

CL/F

次要结局

未报告次要终点

研究者

研究点 (1)

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