NCT06307132

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

A Study on the Correlation of Drug Metabolism, Excretion, and Human Body Composition Based on the Bioequivalence Trial of Aximus Capsules

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence Trial

Interventions

Type	Name	Description
OTHER	Aximus capsules（test）	Aximus capsules test preparation
DRUG	Aximus capsules（reference）	Aximus capsules reference preparation

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-06-30
• Completion: 2024-08-31
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study