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

Active, not recruiting

• Conditions: Bioequivalence Trial
• Interventions: Other: Aximus capsules（test）; Drug: Aximus capsules（reference）

• Registration Number: NCT06307132
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
test preparation	Aximus capsules（test）	-
reference preparation	Aximus capsules（reference）	-

Primary Outcome Measures

Name	Time	Method
Excretion volume	Within 12 hours after taking medication	drug concentration in urine

Trial Locations

Locations (1)

The Second Affiliated Hospital of WMU Phase l Clinical Trial Unit /Center Of Bioequivalence Study; 🇨🇳 Wenzhou, China