跳至主要内容
临床试验/NCT03695107
NCT03695107Unknown不适用

Clinical Study on the Effect of PTH on CYP3A4 Activity

The Third Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
the concentration of nifedipine

研究概览

简要总结

Parathyroid hormone (PTH) may play an important role in the down-regulation of CYP3A4 expression induced by Chronic kidney diseases (CKD). In the study of molecular mechanism, the research group found that the expression of CYP3A2 metabolic enzyme in rat liver decreased in the state of CKD.And PTH may down-regulate the expression of CYP3A4 metabolic enzyme by inhibiting the expression of Nuclear factor- Kilobuse (NF-kB) p65 subunit

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese male or female subjects with an age of 18 or older were included;
  • The clinical physician diagnosed CKD with hypertension;
  • The physician decided that nifedipine controlled release tablets should be given.
  • Subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee;
  • Subjects will be able to communicate well with the investigator and will be able to complete the study as required.

排除标准

  • Patients with CKD requiring dialysis treatment;
  • Other clinical reasons that may be considered inappropriate for inclusion by clinicians.

研究组 & 干预措施

XBDP1-

干预措施: Nifedipine controlled released tablets (Drug)

XBDP2-

干预措施: Nifedipine controlled released tablets (Drug)

结局指标

主要结局

the concentration of nifedipine

时间窗: at 5-7days

the concentration of nifedipine

次要结局

  • 24-hour ambulatory blood pressure(at 1 day and 7day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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