Bioequivalence Trial
Conditions
Brief summary
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.
Interventions
OTHERAximus capsules（test）
Aximus capsules test preparation
DRUGAximus capsules（reference）
Aximus capsules reference preparation
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult men and non-pregnant non-lactating women who successfully participated in the bioequivalence test of acylimus capsules； 2. 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.
Exclusion criteria
1. Female subjects who are menstruating (which may affect urine sample collection); 2. The subjects may not be able to complete this study for other reasons or may not be suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excretion volume | Within 12 hours after taking medication | drug concentration in urine |
Countries
China
Outcome results
None listed