跳至主要内容
临床试验/NL-OMON30712
NL-OMON30712已完成不适用

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of CG5503 Immediate-Release Capsule in Healthy Elderly and Young Subjects - CG5503 IR pharmocokinetics in young and elderly

Johnson & Johnson Pharmaceutical0 个研究点目标入组 32 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • female (surgically sterilized or post-menopausal for at least two years or use for this study an acceptable method of birth control)
  • age 18-45 years
  • age 65 years and older
  • BMI is between 20 - 30 kg/m2 with a weight of not less than 50 kg
  • no smoking or you not smoking more than 10 cigarettes/day
  • Kidney function: for elderly CLCR > 60 mL/min; for young subjects CLCR at least 80 mL/min

排除标准

  • Important medical disorder, e.g., hepatitis B, cancer or HIV/AIDS.
  • Participation in another drug study within 60 days before the start of this study.
  • Blood donation within the 90 days prior to the start of this study or sudden blood loss of similar amount of blood.

研究者

发起方
Johnson & Johnson Pharmaceutical

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