A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Excretion volume
研究概览
简要总结
This project will be based on the bioequivalence test of Aximus capsules, measuring the body composition indicators of healthy subjects before and after medication, and collecting urine samples from subjects at different time periods after medication, measuring urine drug concentration, calculating urine excretion, analyzing the individualized differences in metabolism and excretion of Aximus capsules under different health states of human components, and providing guidance for clinical precision medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules；
- •Signed the informed consent form, and fully understood the content, process and risks of this research, and be able to communicate well with the researchers.
排除标准
- •Female subjects who are menstruating (which may affect urine sample collection);
- •The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.
研究组 & 干预措施
test preparation
干预措施: Aximus capsules（test） (Other)
reference preparation
干预措施: Aximus capsules（reference） (Drug)
结局指标
主要结局
Excretion volume
时间窗: Within 12 hours after taking medication
drug concentration in urine
次要结局
未报告次要终点
研究者
TING LI
chief physician
Second Affiliated Hospital of Wenzhou Medical University