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临床试验/KCT0001431
KCT0001431已完成未知

A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects

Ildong pharmaceutical0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 45(Year)(—)
性别
Male

入选标准

  • 20~45 aged healthy adult.
  • someone tho has at least 50kg body weight and ideal body weight ±20%

排除标准

  • someone has acute symptom at screening phase
  • someone has any disease or symptoms which is clinically significant
  • someone had been determined during healthy examination in screening period
  • AST or ALT > 1.5 times than normal
  • Total bilirubin > 1.5 times than normal
  • someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
  • someone who had enrolled to other clinical trial within the last 60 days.
  • someone who had donated blood within the last 60 days.
  • someone who can't take a meal derived from this trial.
  • someone who has taken abnormal meals like which can affect to drug Absorbtion, Distribution, Metabolism, Excretion
  • someone who has taken other prescription medicine or oriental drugs within the last 14 days, Or over-the-counter drugs within the last 7 days
  • someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
  • someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
  • someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

研究者

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