Drug Metabolism, Excretion, and Human Body Composition of Aximus Capsules

Second Affiliated Hospital of Wenzhou Medical University

Status: Active, not recruiting

Conditions: Bioequivalence Trial

Treatments: Drug: Aximus capsules（reference）; Other: Aximus capsules（test）

Study type: Observational

Funder types: Other

Identifiers

NCT06307132

SAHoWMU-CR2024-03-106

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

test preparation

Treatment:

Other: Aximus capsules（test）

reference preparation

Treatment:

Drug: Aximus capsules（reference）